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A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02185040
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: CC-220
Drug: Placebo
Enrollment 42
Recruitment Details The multi-center study was conducted in the United States. Forty-two participants were enrolled at 11 study sites.
Pre-assignment Details In part 1 of the study, participants were randomly assigned to 1 of 4 dose cohorts; within each cohort participants were randomized in a 4:1 ratio to receive iberdomide or placebo. Participants who completed the Part 1 treatment phase were eligible to receive iberdomide for up to 2 years in the active treatment extension phase (ATEP).
Arm/Group Title Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase. Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase. Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase. Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years. Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Period Title: Part 1 Treatment Phase
Started 8 8 8 9 9 0 0
Completed 7 6 7 7 6 0 0
Not Completed 1 2 1 2 3 0 0
Reason Not Completed
Miscellaneous             0             0             1             0             0             0             0
Adverse Event             1             0             0             2             3             0             0
Withdrawal by Subject             0             1             0             0             0             0             0
Lost to Follow-up             0             1             0             0             0             0             0
Period Title: Active Treatment Extension Phase
Started 0 0 0 0 0 9 8
Completed 0 0 0 0 0 6 1
Not Completed 0 0 0 0 0 3 7
Reason Not Completed
Miscellaneous             0             0             0             0             0             1             0
Adverse Event             0             0             0             0             0             1             4
Withdrawal by Subject             0             0             0             0             0             1             1
Lost to Follow-up             0             0             0             0             0             0             2
Arm/Group Title Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD Total
Hide Arm/Group Description Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase. Participants received 0.3 mg iberdomide capsules QD up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules QD during ATEP up to 2 years. Participants received iberdomide 0.6 mg capsules on alternating (ALT) days with 0.3 mg iberdomide capsules on alternating days up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days during the ATEP up to 2 years. Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 9 9 42
Hide Baseline Analysis Population Description
Intent to Treat (ITT) includes all participants who were randomized and received at least 1 dose of investigational product (IP). Participants were included in the treatment group to which they were randomized for the ITT analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
44.8  (6.58) 46.0  (8.62) 48.0  (10.85) 49.8  (13.07) 47.2  (13.56) 47.2  (10.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
Female
7
  87.5%
8
 100.0%
7
  87.5%
8
  88.9%
9
 100.0%
39
  92.9%
Male
1
  12.5%
0
   0.0%
1
  12.5%
1
  11.1%
0
   0.0%
3
   7.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
Hispanic or Latino
3
  37.5%
1
  12.5%
1
  12.5%
1
  11.1%
1
  11.1%
7
  16.7%
Not Hispanic or Latino
5
  62.5%
7
  87.5%
7
  87.5%
8
  88.9%
8
  88.9%
35
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
Asian
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
Black or African American
2
  25.0%
2
  25.0%
4
  50.0%
1
  11.1%
4
  44.4%
13
  31.0%
White
5
  62.5%
6
  75.0%
4
  50.0%
7
  77.8%
5
  55.6%
27
  64.3%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
   2.4%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
33.029  (5.8922) 30.119  (5.7386) 36.426  (9.9918) 27.012  (4.9291) 28.553  (8.3143) 30.873  (7.6362)
Cutaneous Lupus Area and Severity Index Activity Score (CLASI) Activity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
4.3  (5.90) 17.6  (12.89) 6.3  (9.07) 8.4  (8.63) 12.4  (16.48) 9.8  (11.76)
[1]
Measure Description: The CLASI Activity Score ranges from 0 to 70 and is generated as: erythema scale = 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy = 0 (absent) to 2 (verrucous/hypertrophic). Erythema and hypertrophy scores are assessed in 13 anatomical locations. The presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion), and hair loss is captured (1 = yes; 0 = no); nonscarring alopecia is scored: 0 (absent) to 3 (focal or patchy in ≥ 1 quadrant). Individual component scores are summed. Higher scores = greater cutaneous disease activity.
Hybrid SELENA Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
6.8  (1.83) 8.4  (4.07) 5.5  (2.07) 6.7  (3.16) 5.7  (1.87) 6.6  (2.79)
[1]
Measure Description: The SELENA SLEDAI score measures SLE disease activity of 24 lupus descriptors. Each descriptor receives a positive score if it is present over the previous assessment; a score of '0' = inactive disease; a positive score (from 1 - 8 is based on the importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores assessment period. The SELENA SLEDAI score can range from '0' to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Physician's Global Assessment (PGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 8 participants 8 participants 8 participants 9 participants 9 participants 42 participants
0.95  (0.518) 1.50  (0.648) 1.50  (0.614) 1.22  (0.353) 1.40  (0.598) 1.31  (0.565)
[1]
Measure Description:

The PGA uses a visual analogue scale with ranges from 0 and 3 to indicate worsening of disease. The scoring was as follows:

0 = none

  1. = mild disease
  2. = moderate disease
  3. = severe disease. The PGA is a physician administered instrument used to gauge a participant's overall state of health.
Baseline Swollen Joint Count   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Swollen Joints
Number Analyzed 5 participants 5 participants 6 participants 8 participants 4 participants 28 participants
4.0  (2.12) 5.2  (2.28) 7.0  (5.22) 6.3  (2.49) 4.0  (1.15) 5.5  (3.11)
[1]
Measure Description: Joint swelling was noted as "present" or "absent," with no quantitation of severity. Forty-four joints were evaluated for the presence or absence of swelling. The same evaluator performed the joint assessments for a given participant at the study site at each study visit.
[2]
Measure Analysis Population Description: Participants with least one swollen joint count.
Baseline Tender Joint Count   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 6 participants 6 participants 7 participants 8 participants 6 participants 33 participants
10.0  (7.21) 7.3  (4.97) 14.3  (9.66) 16.9  (9.09) 13.3  (11.29) 12.7  (8.90)
[1]
Measure Description: Joint tenderness was noted as "present" or "absent," with no quantitation of severity. Forty-four joints were evaluated for the presence or absence of swelling. The same evaluator performed the joint assessments for a given participant at the study site at each study visit.
[2]
Measure Analysis Population Description: Participants with at least one tender joint count.
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
Hide Description A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who were randomized and received at least 1 dose of IP. For all participants, this was the treatment group to which they were randomized.
Arm/Group Title Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD
Hide Arm/Group Description:
Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 8 8 8 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
5
  62.5%
7
  87.5%
7
  87.5%
8
  88.9%
8
  88.9%
Any IP-related TEAE
1
  12.5%
2
  25.0%
2
  25.0%
4
  44.4%
6
  66.7%
Any Severe TEAE
1
  12.5%
0
   0.0%
0
   0.0%
1
  11.1%
2
  22.2%
Any Serious TEAE
2
  25.0%
0
   0.0%
0
   0.0%
1
  11.1%
1
  11.1%
Any Serious IP-related TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Any TEAE Leading to IP Interruption
0
   0.0%
0
   0.0%
1
  12.5%
1
  11.1%
5
  55.6%
Any TEAE Leading to IP Withdrawal
1
  12.5%
0
   0.0%
0
   0.0%
2
  22.2%
3
  33.3%
Any TEAE Leading to Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
Hide Description A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
9
 100.0%
7
  87.5%
Any IP-related TEAE
2
  22.2%
5
  62.5%
Any Severe TEAE
0
   0.0%
5
  62.5%
Any Serious TEAE
0
   0.0%
4
  50.0%
Any Serious IP-related TEAE
0
   0.0%
0
   0.0%
Any TEAE Leading to IP Interruption
2
  22.2%
5
  62.5%
Any TEAE Leading to IP Withdrawal
1
  11.1%
4
  50.0%
Any TEAE Leading to Death
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
Hide Description The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
Arm/Group Title Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD
Hide Arm/Group Description:
Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 3 3 5 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
Day 1 Number Analyzed 3 participants 3 participants 5 participants 4 participants
10.82
(17.9%)
11.29
(42.6%)
34.15
(45.5%)
38.73
(76.5%)
Day 29 Number Analyzed 3 participants 3 participants 4 participants 3 participants
13.34
(14.1%)
15.55
(1.8%)
24.85
(110.5%)
52.65
(82.4%)
4.Secondary Outcome
Title Maximum Observed Concentration (Cmax) Of Iberdomide
Hide Description Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
Arm/Group Title Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD
Hide Arm/Group Description:
Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 3 3 5 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 3 participants 1 participants 5 participants 4 participants
0.90
(41.3%)
0.64
(42.4%)
2.92
(50.6%)
2.35
(63.1%)
Day 29 Number Analyzed 3 participants 3 participants 4 participants 3 participants
1.02
(4.3%)
1.09
(1.8%)
2.37
(42.7%)
3.51
(51.7%)
5.Secondary Outcome
Title Time to Reach Maximum Concentration (Tmax) of Iberdomide
Hide Description Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
Arm/Group Title Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD
Hide Arm/Group Description:
Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 3 3 5 4
Median (Full Range)
Unit of Measure: days
Day 1 Number Analyzed 3 participants 1 participants 5 participants 4 participants
4.00
(2.0 to 4.0)
6.00
(3.0 to 25.8)
1.92
(0.95 to 4.0)
4.01
(2.0 to 27.3)
Day 29 Number Analyzed 3 participants 3 participants 4 participants 3 participants
4.00
(2.05 to 4.08)
2.00
(2.0 to 3.05)
3.00
(1.0 to 4.0)
2.02
(1.1 to 3.1)
6.Secondary Outcome
Title Terminal Phase Half-Life (T1/2) Of Iberdomide
Hide Description Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic population included all participants in the safety population with at least one non-missing plasma concentration datum available.
Arm/Group Title Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.6 mg QD
Hide Arm/Group Description:
Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 1 3 5 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
Day 1 Number Analyzed 1 participants 1 participants 3 participants 2 participants
7.50 [1] 
(NA%)
10.25 [1] 
(NA%)
7.96
(22.8%)
9.55
(0.2%)
Day 29 Number Analyzed 1 participants 3 participants 2 participants 2 participants
8.46 [1] 
(NA%)
11.85
(4.1%)
9.39
(11.1%)
11.32
(4.8%)
[1]
NA = Due to small sample size, the GCV% could not be calculated.
7.Secondary Outcome
Title Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
Hide Description The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP. The number analyzed at each time point includes participants with a baseline value >= 4 and non-missing post-baseline value.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 Number Analyzed 7 participants 8 participants
0.0 12.5
Week 4 Number Analyzed 7 participants 7 participants
0.0 14.3
Week 12 Number Analyzed 6 participants 7 participants
66.7 0.0
Week 24 Number Analyzed 6 participants 5 participants
83.3 20.0
Week 36 Number Analyzed 6 participants 4 participants
66.7 0.0
Week 48 Number Analyzed 6 participants 5 participants
50.0 20.0
Week 60 Number Analyzed 6 participants 5 participants
33.3 20.0
Week 72 Number Analyzed 5 participants 3 participants
80.0 0.0
Week 84 Number Analyzed 5 participants 2 participants
80.0 0.0
Week 96 Number Analyzed 5 participants 1 participants
40.0 0.0
Week 100 Follow-Up Number Analyzed 5 participants 4 participants
40.0 0.0
8.Secondary Outcome
Title Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
Hide Description The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
0.2  (1.56) -1.0  (2.39)
Week 4 Number Analyzed 9 participants 7 participants
0.2  (1.56) -1.7  (2.93)
Week 12 Number Analyzed 8 participants 7 participants
-1.8  (2.92) -0.9  (1.07)
Week 24 Number Analyzed 8 participants 5 participants
-2.8  (2.60) -1.2  (2.59)
Week 36 Number Analyzed 7 participants 4 participants
-3.1  (1.95) 0.3  (2.06)
Week 48 Number Analyzed 7 participants 5 participants
-2.9  (1.95) -1.0  (2.65)
Week 60 Number Analyzed 7 participants 5 participants
-2.6  (1.90) -1.8  (4.02)
Week 72 Number Analyzed 6 participants 3 participants
-3.0  (1.67) -1.3  (1.15)
Week 84 Number Analyzed 6 participants 2 participants
-3.0  (1.67) -1.0  (1.41)
Week 96 Number Analyzed 6 participants 1 participants
-2.0  (1.79) 0.0 [1]   (NA)
Week 100 Follow-Up Number Analyzed 7 participants 4 participants
-1.7  (2.43) 0.3  (1.71)
[1]
NA = Could not be calculated due to the low number of participants with available data.
9.Secondary Outcome
Title Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Hide Description Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Joints
Week 1 Number Analyzed 9 participants 8 participants
-1.2  (3.11) -0.4  (0.74)
Week 4 Number Analyzed 9 participants 7 participants
-1.8  (2.99) -0.6  (2.64)
Week 12 Number Analyzed 8 participants 7 participants
-2.6  (4.81) -0.3  (0.95)
Week 24 Number Analyzed 8 participants 5 participants
-2.1  (5.84) 1.2  (1.30)
Week 36 Number Analyzed 7 participants 5 participants
-3.9  (4.67) -0.2  (2.17)
Week 48 Number Analyzed 7 participants 5 participants
-3.6  (5.35) 0.6  (1.34)
Week 60 Number Analyzed 7 participants 5 participants
-2.6  (5.74) 0.4  (1.52)
Week 72 Number Analyzed 6 participants 3 participants
-4.0  (5.10) 0.7  (1.15)
Week 84 Number Analyzed 6 participants 2 participants
-4.2  (5.49) 0.0  (0.00)
Week 96 Number Analyzed 6 participants 1 participants
-3.7  (5.75) 0.0 [1]   (NA)
Week 100 Follow-Up Number Analyzed 7 participants 5 participants
-3.6  (5.26) -0.4  (0.55)
[1]
NA = Could not be calculated due to the low number of participants with available data.
10.Secondary Outcome
Title Change From Baseline in Tender Joint Count During the ATEP by Time Point
Hide Description Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Joints
Week 1 Number Analyzed 9 participants 8 participants
-0.9  (2.37) -2.5  (4.63)
Week 4 Number Analyzed 9 participants 7 participants
-0.9  (3.76) -2.0  (3.27)
Week 12 Number Analyzed 8 participants 7 participants
0.5  (6.02) -3.7  (7.67)
Week 24 Number Analyzed 8 participants 5 participants
-3.9  (4.19) -3.6  (10.97)
Week 36 Number Analyzed 7 participants 5 participants
-5.1  (5.30) -3.8  (9.65)
Week 48 Number Analyzed 7 participants 5 participants
-5.9  (6.99) -3.0  (8.97)
Week 60 Number Analyzed 7 participants 5 participants
-5.6  (9.78) -4.4  (10.99)
Week 72 Number Analyzed 6 participants 3 participants
-6.2  (6.59) -6.7  (12.42)
Week 84 Number Analyzed 6 participants 2 participants
-7.3  (10.78) 0.0  (0.00)
Week 96 Number Analyzed 6 participants 1 participants
-7.0  (7.92) 0.0 [1]   (NA)
Week 100 Follow-Up Number Analyzed 7 participants 5 participants
-4.1  (3.63) -1.4  (3.44)
[1]
NA = Could not be calculated due to the low number of participants with available data.
11.Secondary Outcome
Title Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
Hide Description The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Percent Change
Week 1 Number Analyzed 7 participants 7 participants
-21.40  (40.529) -13.35  (28.556)
Week 4 Number Analyzed 7 participants 6 participants
-32.13  (45.400) -18.32  (58.924)
Week 12 Number Analyzed 6 participants 6 participants
-18.42  (68.423) -36.46  (33.648)
Week 24 Number Analyzed 6 participants 4 participants
13.54  (147.030) -44.69  (24.366)
Week 36 Number Analyzed 5 participants 4 participants
-0.56  (116.911) -43.98  (31.724)
Week 48 Number Analyzed 5 participants 4 participants
-46.97  (44.154) -46.00  (22.343)
Week 60 Number Analyzed 5 participants 4 participants
-65.64  (40.889) -47.51  (28.871)
Week 72 Number Analyzed 4 participants 2 participants
-55.13  (41.583) -40.35  (9.924)
Week 84 Number Analyzed 4 participants 2 participants
-65.71  (24.535) -32.46  (1.241)
Week 96 Number Analyzed 4 participants 1 participants
-75.38  (23.492) -26.32 [1]   (NA)
Follow-Up Week 100 Number Analyzed 5 participants 5 participants
-53.04  (39.635) -18.82  (37.296)
[1]
NA = Could not be calculated due to the low number of participants with available data.
12.Secondary Outcome
Title Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
Hide Description

The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows:

  • 0 = none
  • 1 = mild disease
  • 2 = moderate disease
  • 3 = severe disease
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
-0.08  (0.139) -0.10  (0.245)
Week 4 Number Analyzed 9 participants 7 participants
-0.26  (0.510) -0.17  (0.407)
Week 12 Number Analyzed 8 participants 7 participants
-0.15  (0.407) -0.31  (0.389)
Week 24 Number Analyzed 8 participants 5 participants
-0.28  (0.686) -0.20  (0.394)
Week 36 Number Analyzed 7 participants 5 participants
-0.30  (0.141) -0.36  (0.590)
Week 48 Number Analyzed 7 participants 5 participants
-0.53  (0.556) -0.26  (0.594)
Week 60 Number Analyzed 7 participants 5 participants
-0.37  (0.550) -0.24  (0.498)
Week 72 Number Analyzed 6 participants 3 participants
-0.48  (0.471) -0.23  (0.666)
Week 84 Number Analyzed 6 participants 2 participants
-0.57  (0.468) -0.30  (0.707)
Week 96 Number Analyzed 6 participants 1 participants
-0.52  (0.595) -0.20 [1]   (NA)
Follow-Up Week 100 Number Analyzed 7 participants 5 participants
-0.21  (0.769) 0.10  (0.354)
[1]
NA = Could not be calculated due to the low number of participants with available data.
13.Secondary Outcome
Title Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
Hide Description The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 8 participants 7 participants
-0.5  (5.76) 3.3  (5.38)
Week 4 Number Analyzed 6 participants 6 participants
2.0  (7.04) 0.7  (9.03)
Week 12 Number Analyzed 5 participants 6 participants
-2.2  (6.98) 2.0  (6.03)
Week 24 Number Analyzed 7 participants 4 participants
-6.3  (6.55) 3.0  (5.60)
Global Score Week 36 Number Analyzed 7 participants 5 participants
-7.3  (5.74) 1.6  (9.13)
Week 48 Number Analyzed 7 participants 5 participants
-6.1  (7.84) 1.4  (5.68)
Week 60 Number Analyzed 7 participants 5 participants
-6.3  (6.37) 0.4  (4.83)
Week 72 Number Analyzed 6 participants 3 participants
-7.5  (4.46) 4.3  (8.50)
Week 84 Number Analyzed 6 participants 2 participants
-7.8  (8.04) -1.0  (1.41)
Week 96 Number Analyzed 6 participants 1 participants
-0.52  (0.595) -0.20 [1]   (NA)
Follow-Up Week 100 Number Analyzed 6 participants 5 participants
-6.3  (7.20) -3.9  (4.62)
[1]
NA = Could not be calculated due to the low number of participants with available data.
14.Secondary Outcome
Title Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
Hide Description The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
-1.0  (2.65) 0.8  (1.49)
Week 4 Number Analyzed 9 participants 7 participants
-0.8  (2.74) 0.9  (2.01)
Week 12 Number Analyzed 9 participants 7 participants
-1.1  (2.67) 1.3  (2.21)
Week 24 Number Analyzed 8 participants 5 participants
-1.0  (2.88) 0.6  (1.34)
Week 36 Number Analyzed 7 participants 5 participants
-0.7  (3.30) 0.7  (1.57)
Week 48 Number Analyzed 7 participants 5 participants
-1.4  (2.99) 0.9  (2.01)
Week 60 Number Analyzed 7 participants 5 participants
-1.1  (3.18) 1.1  (2.41)
Week 72 Number Analyzed 6 participants 3 participants
0.2  (1.57) 0.0  (0.00)
Week 84 Number Analyzed 6 participants 2 participants
0.2  (0.98) 0.0  (0.00)
Week 96 Number Analyzed 6 participants 1 participants
-0.2  (0.98) 0.0 [1]   (NA)
Follow-Up Week 100 Number Analyzed 7 participants 5 participants
-0.6  (0.98) 0.2  (1.10)
[1]
NA = Could not be calculated due to the low number of participants with available data.
15.Secondary Outcome
Title Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
Hide Description The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
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Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
-10.0  (20.30) -4.0  (13.48)
Week 4 Number Analyzed 9 participants 7 participants
-4.1  (16.96) -3.7  (12.23)
Week 12 Number Analyzed 9 participants 7 participants
-15.9  (30.77) -8.0  (20.60)
Week 24 Number Analyzed 8 participants 5 participants
-13.6  (17.27) -4.0  (8.80)
Week 36 Number Analyzed 7 participants 5 participants
-21.1  (20.96) -17.2  (17.48)
Week 48 Number Analyzed 7 participants 5 participants
-29.9  (20.58) -12.8  (14.48)
Week 60 Number Analyzed 7 participants 5 participants
-23.0  (20.65) -12.6  (10.74)
Week 72 Number Analyzed 6 participants 3 participants
-22.8  (26.96) -25.7  (19.55)
Week 84 Number Analyzed 6 participants 2 participants
-10.3  (24.61) -14.0  (19.80)
Week 96 Number Analyzed 6 participants 1 participants
-9.8  (34.52) -20.0 [1]   (NA)
[1]
NA = Could not be calculated due to the low number of participants with available data.
16.Secondary Outcome
Title Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
Hide Description The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
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Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
-0.1  (0.33) 0.0  (0.00)
Week 4 Number Analyzed 9 participants 7 participants
0.0  (0.00) -1.0  (2.24)
Week 12 Number Analyzed 8 participants 7 participants
-0.6  (1.77) -0.9  (2.73)
Week 24 Number Analyzed 8 participants 5 participants
0.1  (0.83) -2.2  (4.38)
Week 36 Number Analyzed 7 participants 5 participants
0.1  (0.38) -2.2  (4.38)
Week 48 Number Analyzed 7 participants 5 participants
0.3  (0.76) -2.4  (4.83)
Week 60 Number Analyzed 7 participants 5 participants
0.4  (0.79) -2.6  (5.81)
Week 72 Number Analyzed 6 participants 3 participants
0.3  (0.82) -0.7  (1.15)
Week 84 Number Analyzed 6 participants 2 participants
0.7  (1.63) -1.0  (1.41)
Week 96 Number Analyzed 6 participants 1 participants
0.0  (0.00) 0.0 [1]   (NA)
Follow-Up Week 100 Number Analyzed 7 participants 5 participants
-0.3  (1.25) 0.0  (0.00)
[1]
NA = Could not be calculated due to the low number of participants with available data.
17.Secondary Outcome
Title Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
Hide Description SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Hide Outcome Measure Data
Hide Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
Arm/Group Title ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Hide Arm/Group Description:
Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 9 participants 8 participants
-0.1  (0.33) 0.0  (0.00)
Week 4 Number Analyzed 9 participants 7 participants
-0.1  (0.33) -0.1  (0.38)
Week 12 Number Analyzed 8 participants 7 participants
-0.1  (0.35) -0.1  (0.38)
Week 24 Number Analyzed 8 participants 5 participants
-0.1  (0.35) -0.2  (0.45)
Week 36 Number Analyzed 7 participants 5 participants
0.0  (0.00) -0.2  (0.45)
Week 48 Number Analyzed 7 participants 5 participants
0.0  (0.00) -0.2  (0.45)
Week 60 Number Analyzed 7 participants 5 participants
0.0  (0.00) -0.2  (0.45)
Week 72 Number Analyzed 6 participants 3 participants
0.0  (0.00) 0.0  (0.00)
Week 84 Number Analyzed 6 participants 2 participants
0.0  (0.00) 0.0  (0.00)
Week 96 Number Analyzed 6 participants 1 participants
0.0  (0.00) 0.0 [1]   (NA)
Follow-Up Week 100 Number Analyzed 7 participants 5 participants
0.6  (1.13) 0.0  (0.00)
[1]
NA = Could not be calculated due to the low number of participants with available data.
Time Frame TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose of IP or study IP discontinuation in Part 1; median treatment duration was 12.0 weeks for the placebo, 0.3 mg Iberdomide QOD and 0.3 mg QD cohorts and 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts
Adverse Event Reporting Description For the ATEP, TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose or study IP discontinuation; median duration of treatment was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
 
Arm/Group Title Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Hide Arm/Group Description Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase. Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.6 mg and 0.3 mg on alternating days for up to 84 days during the Part 1 treatment phase. Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase. Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years. Participants originally randomized to iberdomide 0.6 mg capsules QD or 0.6 mg Iberdomide capsules alternating days with 0.3 mg iberdomide capsules or placebo capsules QD chorts (in these respective groups), during the Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days when entered into the active treatment extension phase up to 2 years.
All-Cause Mortality
Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   0/8 (0.00%)   0/8 (0.00%)   1/9 (11.11%)   1/9 (11.11%)   0/9 (0.00%)   4/8 (50.00%) 
Eye disorders               
Vitreous detachment  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Infections and infestations               
Pneumonia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders               
Systemic lupus erythematosus  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Nervous system disorders               
Seizure  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Psychiatric disorders               
Schizoaffective disorder  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Vascular disorders               
Deep vein thrombosis  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   7/8 (87.50%)   7/8 (87.50%)   8/9 (88.89%)   8/9 (88.89%)   9/9 (100.00%)   7/8 (87.50%) 
Blood and lymphatic system disorders               
Eosinophilia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Neutropenia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  2/9 (22.22%)  1/9 (11.11%)  1/8 (12.50%) 
Cardiac disorders               
Palpitations  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Ear and labyrinth disorders               
Vertigo  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Eye disorders               
Dry eye  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Episcleritis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Eye pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Keratitis  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Lacrimation increased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Ocular discomfort  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Retinopathy hypertensive  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Scleritis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Abdominal pain upper  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Cheilitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Constipation  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Dental caries  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Dental necrosis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Diarrhoea  1  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  2/9 (22.22%)  2/9 (22.22%)  1/9 (11.11%)  3/8 (37.50%) 
Duodenal polyp  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Dyspepsia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Flatulence  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Food poisoning  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Gastritis  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Gastrooesophageal reflux disease  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Gingival bleeding  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Hiatus hernia  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Lip blister  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nausea  1  1/8 (12.50%)  1/8 (12.50%)  3/8 (37.50%)  3/9 (33.33%)  0/9 (0.00%)  2/9 (22.22%)  0/8 (0.00%) 
Pancreatitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Toothache  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Vomiting  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
General disorders               
Gait disturbance  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  2/9 (22.22%)  0/8 (0.00%) 
Influenza like illness  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Oedema peripheral  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Swelling  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Infections and infestations               
Acute sinusitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Bacteriuria  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Bronchitis  1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/9 (0.00%)  3/9 (33.33%)  3/8 (37.50%) 
Conjunctivitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Ear infection  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Folliculitis  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Gastroenteritis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Herpes virus infection  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Hordeolum  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Influenza  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Laryngitis  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Lyme disease  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nasopharyngitis  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  2/9 (22.22%)  0/8 (0.00%) 
Onychomycosis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Oral candidiasis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Pharyngitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Pneumonia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/9 (11.11%)  1/8 (12.50%) 
Sinusitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  2/9 (22.22%)  1/8 (12.50%) 
Staphylococcal infection  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Tooth abscess  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Upper respiratory tract infection  1  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/9 (11.11%)  1/9 (11.11%)  4/9 (44.44%)  3/8 (37.50%) 
Urinary tract infection  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  2/9 (22.22%)  2/8 (25.00%) 
Viral upper respiratory tract infection  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Injury, poisoning and procedural complications               
Contusion  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  2/9 (22.22%)  0/8 (0.00%) 
Laceration  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Investigations               
Hepatic enzyme increased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Neutrophil count decreased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Weight increased  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders               
Hypovitaminosis  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Vitamin D deficiency  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/9 (22.22%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  1/8 (12.50%) 
Back pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Bursitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Fibromyalgia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Muscle spasms  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Muscle twitching  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Muscular weakness  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Musculoskeletal pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  2/8 (25.00%) 
Neck pain  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Osteoarthritis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  2/9 (22.22%)  0/8 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  2/9 (22.22%)  0/8 (0.00%) 
Synovial cyst  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Systemic lupus erythematosus  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nervous system disorders               
Dizziness  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  2/8 (25.00%) 
Headache  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Lethargy  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nerve root compression  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Small fibre neuropathy  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Psychiatric disorders               
Anxiety  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Generalised anxiety disorder  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Insomnia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Irritability  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Middle insomnia  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders               
Pollakiuria  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Stress urinary incontinence  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Urinary incontinence  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Reproductive system and breast disorders               
Cervical polyp  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Dysmenorrhoea  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Galactorrhoea  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Menorrhagia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Menstruation irregular  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Nipple disorder  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Asthma  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Cough  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  2/8 (25.00%) 
Dyspnoea  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Pleuritic pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Pulmonary embolism  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Sinus congestion  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Angioedema  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Blister  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Dermatitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  2/9 (22.22%)  0/9 (0.00%)  0/8 (0.00%) 
Ecchymosis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Hidradenitis  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Nail discolouration  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Pain of skin  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Prurigo  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Pruritus  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Rash follicular  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Rash macular  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Rash maculo-papular  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Rash papular  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Skin lesion  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Urticaria  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Vascular disorders               
Deep vein thrombosis  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 866-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02185040    
Other Study ID Numbers: CC-220-SLE-001
First Submitted: July 7, 2014
First Posted: July 9, 2014
Results First Submitted: September 24, 2019
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020