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Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis

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: NCT02520284
Recruitment Status : Terminated
First Posted : August 11, 2015
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Biological: Andecaliximab
Biological: Placebo
Enrollment 165
Recruitment Details Participants were enrolled at study sites in South Africa, Europe, North America, and Asia Pacific. The first participant was screened on 15 September 2015. The last study visit occurred on 22 November 2016.
Pre-assignment Details 241 participants were screened.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission and/or Mayo Clinical Score (MCS) response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Period Title: Blinded Induction Phase: Up to Week 8
Started 54 56 55
Completed 52 52 [1] 53 [1]
Not Completed 2 4 2
Reason Not Completed
Adverse Event             1             3             0
Withdrew Consent             1             1             1
Study Terminated by Sponsor             0             0             1
[1]
1 Participant completed Blinded Induction Phase but did not continue further in study.
Period Title: Blinded Maintenance Phase: Up to Week 51
Started 20 [1] 16 [1] 18 [1]
Completed 0 0 0
Not Completed 20 16 18
Reason Not Completed
Study Terminated by Sponsor             17             11             15
Disease Worsening             2             2             3
Adverse Event             1             1             0
Disposition Error             0             2             0
[1]
Participants achieving EBS remission and/or MCS response continued in Blinded Maintenance Phase.
Period Title: Open-Label MaintenancePhase: Upto Week51
Started 32 [1] 35 [1] 34 [1]
Completed 0 0 0
Not Completed 32 35 34
Reason Not Completed
Study Terminated by Sponsor             25             29             28
Withdrew Consent             3             4             2
Adverse Event             2             1             3
Investigator's Discretion             2             1             1
[1]
Participants achieving neither EBS remission nor MCS response entered Open-Label Maintenance Phase.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo Total
Hide Arm/Group Description

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 54 56 55 165
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 56 participants 55 participants 165 participants
44  (14.1) 43  (13.2) 43  (12.8) 43  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 55 participants 165 participants
Female
19
  35.2%
18
  32.1%
24
  43.6%
61
  37.0%
Male
35
  64.8%
38
  67.9%
31
  56.4%
104
  63.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 54 participants 56 participants 55 participants 165 participants
White
48
  88.9%
48
  85.7%
45
  81.8%
141
  85.5%
Black
4
   7.4%
3
   5.4%
3
   5.5%
10
   6.1%
Asian
2
   3.7%
4
   7.1%
4
   7.3%
10
   6.1%
Native Hawaiian or Pacific Islander
0
   0.0%
0
   0.0%
1
   1.8%
1
   0.6%
Not Permitted
0
   0.0%
0
   0.0%
1
   1.8%
1
   0.6%
Other
0
   0.0%
1
   1.8%
1
   1.8%
2
   1.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 54 participants 56 participants 55 participants 165 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
   3.6%
2
   1.2%
Not Hispanic or Latino
54
 100.0%
56
 100.0%
51
  92.7%
161
  97.6%
Not Permitted
0
   0.0%
0
   0.0%
2
   3.6%
2
   1.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 55 participants 165 participants
Romania
4
   7.4%
2
   3.6%
1
   1.8%
7
   4.2%
Hungary
1
   1.9%
2
   3.6%
2
   3.6%
5
   3.0%
United States
20
  37.0%
20
  35.7%
21
  38.2%
61
  37.0%
Czechia
1
   1.9%
0
   0.0%
1
   1.8%
2
   1.2%
Ukraine
3
   5.6%
3
   5.4%
3
   5.5%
9
   5.5%
United Kingdom
2
   3.7%
2
   3.6%
2
   3.6%
6
   3.6%
Switzerland
0
   0.0%
2
   3.6%
0
   0.0%
2
   1.2%
Russia
2
   3.7%
4
   7.1%
4
   7.3%
10
   6.1%
New Zealand
0
   0.0%
3
   5.4%
1
   1.8%
4
   2.4%
Canada
0
   0.0%
2
   3.6%
3
   5.5%
5
   3.0%
South Korea
2
   3.7%
3
   5.4%
2
   3.6%
7
   4.2%
Latvia
1
   1.9%
0
   0.0%
0
   0.0%
1
   0.6%
Netherlands
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.6%
Belgium
1
   1.9%
3
   5.4%
2
   3.6%
6
   3.6%
Ireland
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.6%
Taiwan
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.6%
Poland
11
  20.4%
4
   7.1%
8
  14.5%
23
  13.9%
Italy
0
   0.0%
2
   3.6%
2
   3.6%
4
   2.4%
South Africa
1
   1.9%
1
   1.8%
0
   0.0%
2
   1.2%
Slovakia
1
   1.9%
0
   0.0%
0
   0.0%
1
   0.6%
Australia
3
   5.6%
0
   0.0%
2
   3.6%
5
   3.0%
Bulgaria
1
   1.9%
0
   0.0%
0
   0.0%
1
   0.6%
France
0
   0.0%
0
   0.0%
1
   1.8%
1
   0.6%
1.Primary Outcome
Title For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
Hide Description EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least 1 dose of study drug in the Blinded Induction Phase (Cohort 1).
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.4
(2.1 to 17.9)
1.8
(0.0 to 9.6)
7.3
(2.0 to 17.6)
2.Secondary Outcome
Title For Cohort 1, Percentage of Participants With MCS Remission at Week 8
Hide Description The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of ≤ 2 points and no individual subscore > 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.4
(2.1 to 17.9)
1.8
(0.0 to 9.6)
7.3
(2.0 to 17.6)
3.Secondary Outcome
Title For Cohort 1, Percentage of Participants With MCS Response at Week 8
Hide Description The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening. The MCS response was defined as a MCS reduction of ≥ 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.3
(32.6 to 60.4)
30.4
(18.8 to 44.1)
30.9
(19.1 to 44.8)
4.Secondary Outcome
Title For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
Hide Description Endoscopic remission was defined as endoscopic subscore of 0. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.7
(0.5 to 12.7)
0.0
(0.0 to 6.4)
5.5
(1.1 to 15.1)
5.Secondary Outcome
Title For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
Hide Description Endoscopic response was defined as endoscopic subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.5
(9.3 to 31.4)
7.1
(2.0 to 17.3)
14.5
(6.5 to 26.7)
6.Secondary Outcome
Title For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8
Hide Description Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of ≤ 3 for Grade 0 (Structural Architectural Change), ≤ 1 for Grade 1 (Chronic Inflammatory Infiltrate), ≤ 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). Total Geboes histologic score ranged from 0 to 22, with higher scores indicating greater disease severity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who did not meet the mucosal healing definition at baseline were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 50 51 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.0
(8.6 to 31.4)
13.7
(5.7 to 26.3)
22.0
(11.5 to 36.0)
7.Secondary Outcome
Title For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8
Hide Description The MCS remission (alternative definition) was defined as a rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA subscore (range: 0 to 3 with higher score indicating the severe disease) of 0, and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]) of 0 or 1 for an overall MCS of ≤ 1. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo
Hide Arm/Group Description:

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.

Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.

Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Overall Number of Participants Analyzed 54 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.9
(0.0 to 9.9)
0.0
(0.0 to 6.4)
0.0
(0.0 to 6.5)
Time Frame Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
 
Arm/Group Title Blinded Induction Phase: Andecaliximab Every 2 Weeks Blinded Induction Phase: Andecaliximab Every Weeks Blinded Induction Phase: Placebo Blinded Maintenance Phase: Andecaliximab Every 2 Weeks Blinded Maintenance Phase: Andecaliximab Every Week Blinded Maintenance Phase: Placebo Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks Open-Label Maintenance Phase From Andecaliximab Every Week Open-Label Maintenance Phase From Placebo
Hide Arm/Group Description Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks. Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks. Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks. Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks. Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
All-Cause Mortality
Blinded Induction Phase: Andecaliximab Every 2 Weeks Blinded Induction Phase: Andecaliximab Every Weeks Blinded Induction Phase: Placebo Blinded Maintenance Phase: Andecaliximab Every 2 Weeks Blinded Maintenance Phase: Andecaliximab Every Week Blinded Maintenance Phase: Placebo Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks Open-Label Maintenance Phase From Andecaliximab Every Week Open-Label Maintenance Phase From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/56 (0.00%)   0/55 (0.00%)   0/20 (0.00%)   0/16 (0.00%)   0/18 (0.00%)   0/32 (0.00%)   0/35 (0.00%)   0/34 (0.00%) 
Hide Serious Adverse Events
Blinded Induction Phase: Andecaliximab Every 2 Weeks Blinded Induction Phase: Andecaliximab Every Weeks Blinded Induction Phase: Placebo Blinded Maintenance Phase: Andecaliximab Every 2 Weeks Blinded Maintenance Phase: Andecaliximab Every Week Blinded Maintenance Phase: Placebo Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks Open-Label Maintenance Phase From Andecaliximab Every Week Open-Label Maintenance Phase From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   2/56 (3.57%)   1/55 (1.82%)   1/20 (5.00%)   2/16 (12.50%)   1/18 (5.56%)   1/32 (3.13%)   3/35 (8.57%)   2/34 (5.88%) 
Blood and lymphatic system disorders                   
Anaemia  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Cardiac disorders                   
Angina pectoris  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Gastrointestinal disorders                   
Colitis ulcerative  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  1/32 (3.13%)  1/35 (2.86%)  1/34 (2.94%) 
Inguinal hernia  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Hepatobiliary disorders                   
Biliary dilatation  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Infections and infestations                   
Anal abscess  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Cytomegalovirus infection  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Nervous system disorders                   
Cerebrovascular accident  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders                   
Nephrolithiasis  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Blinded Induction Phase: Andecaliximab Every 2 Weeks Blinded Induction Phase: Andecaliximab Every Weeks Blinded Induction Phase: Placebo Blinded Maintenance Phase: Andecaliximab Every 2 Weeks Blinded Maintenance Phase: Andecaliximab Every Week Blinded Maintenance Phase: Placebo Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks Open-Label Maintenance Phase From Andecaliximab Every Week Open-Label Maintenance Phase From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/54 (44.44%)   31/56 (55.36%)   26/55 (47.27%)   12/20 (60.00%)   12/16 (75.00%)   13/18 (72.22%)   9/32 (28.13%)   6/35 (17.14%)   12/34 (35.29%) 
Blood and lymphatic system disorders                   
Anaemia  1  4/54 (7.41%)  4/56 (7.14%)  2/55 (3.64%)  3/20 (15.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  1/35 (2.86%)  3/34 (8.82%) 
Thrombocytosis  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Ear and labyrinth disorders                   
Ear discomfort  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Eye disorders                   
Dry eye  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Gastrointestinal disorders                   
Abdominal discomfort  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Abdominal distension  1  0/54 (0.00%)  1/56 (1.79%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  1/18 (5.56%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Abdominal pain  1  1/54 (1.85%)  2/56 (3.57%)  5/55 (9.09%)  1/20 (5.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Colitis ulcerative  1  2/54 (3.70%)  3/56 (5.36%)  1/55 (1.82%)  2/20 (10.00%)  1/16 (6.25%)  4/18 (22.22%)  1/32 (3.13%)  1/35 (2.86%)  3/34 (8.82%) 
Dyschezia  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Frequent bowel movements  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Haematochezia  1  1/54 (1.85%)  0/56 (0.00%)  1/55 (1.82%)  1/20 (5.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Haemorrhoids  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Inguinal hernia  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Mouth ulceration  1  2/54 (3.70%)  2/56 (3.57%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Nausea  1  2/54 (3.70%)  3/56 (5.36%)  3/55 (5.45%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  2/32 (6.25%)  0/35 (0.00%)  0/34 (0.00%) 
Rectal haemorrhage  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
General disorders                   
Fatigue  1  1/54 (1.85%)  1/56 (1.79%)  3/55 (5.45%)  1/20 (5.00%)  1/16 (6.25%)  1/18 (5.56%)  2/32 (6.25%)  0/35 (0.00%)  1/34 (2.94%) 
Feeling hot  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Influenza like illness  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  1/20 (5.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Injection site bruising  1  1/54 (1.85%)  4/56 (7.14%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Injection site erythema  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Injection site hypersensitivity  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Peripheral swelling  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  1/32 (3.13%)  0/35 (0.00%)  1/34 (2.94%) 
Pyrexia  1  1/54 (1.85%)  4/56 (7.14%)  1/55 (1.82%)  1/20 (5.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Thirst  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Immune system disorders                   
Hypersensitivity  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Infections and infestations                   
Cellulitis  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Clostridium difficile infection  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Folliculitis  1  0/54 (0.00%)  1/56 (1.79%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Gastroenteritis  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  2/34 (5.88%) 
Nasopharyngitis  1  2/54 (3.70%)  2/56 (3.57%)  2/55 (3.64%)  0/20 (0.00%)  2/16 (12.50%)  2/18 (11.11%)  1/32 (3.13%)  1/35 (2.86%)  0/34 (0.00%) 
Rhinitis  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Sinusitis  1  0/54 (0.00%)  3/56 (5.36%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  1/35 (2.86%)  1/34 (2.94%) 
Urinary tract infection  1  2/54 (3.70%)  2/56 (3.57%)  0/55 (0.00%)  1/20 (5.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications                   
Injection related reaction  1  0/54 (0.00%)  0/56 (0.00%)  2/55 (3.64%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Radius fracture  1  1/54 (1.85%)  0/56 (0.00%)  1/55 (1.82%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Investigations                   
Blood creatine phosphokinase increased  1  1/54 (1.85%)  0/56 (0.00%)  2/55 (3.64%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Haemoglobin decreased  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Lymphocyte count decreased  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Fluid retention  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Hyperglycaemia  1  0/54 (0.00%)  4/56 (7.14%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Hypophosphataemia  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Iron deficiency  1  1/54 (1.85%)  1/56 (1.79%)  0/55 (0.00%)  1/20 (5.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  1/54 (1.85%)  3/56 (5.36%)  3/55 (5.45%)  1/20 (5.00%)  3/16 (18.75%)  3/18 (16.67%)  0/32 (0.00%)  2/35 (5.71%)  1/34 (2.94%) 
Back pain  1  1/54 (1.85%)  3/56 (5.36%)  2/55 (3.64%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Muscle spasms  1  0/54 (0.00%)  1/56 (1.79%)  2/55 (3.64%)  0/20 (0.00%)  1/16 (6.25%)  2/18 (11.11%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Muscular weakness  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Musculoskeletal discomfort  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Musculoskeletal stiffness  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Pain in jaw  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Nervous system disorders                   
Dizziness  1  0/54 (0.00%)  1/56 (1.79%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  2/18 (11.11%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Headache  1  2/54 (3.70%)  4/56 (7.14%)  1/55 (1.82%)  0/20 (0.00%)  2/16 (12.50%)  1/18 (5.56%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Lethargy  1  0/54 (0.00%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Polyneuropathy  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Sciatica  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Psychiatric disorders                   
Depression  1  1/54 (1.85%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders                   
Haematuria  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Reproductive system and breast disorders                   
Menstrual disorder  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Uterine prolapse  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough  1  1/54 (1.85%)  3/56 (5.36%)  1/55 (1.82%)  0/20 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Dyspnoea  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Upper respiratory tract inflammation  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Skin and subcutaneous tissue disorders                   
Acne  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Alopecia  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Dry skin  1  1/54 (1.85%)  0/56 (0.00%)  1/55 (1.82%)  0/20 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Erythema  1  0/54 (0.00%)  2/56 (3.57%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Erythema nodosum  1  0/54 (0.00%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Night sweats  1  1/54 (1.85%)  1/56 (1.79%)  0/55 (0.00%)  1/20 (5.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Onychoclasis  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Psoriasis  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Rash  1  1/54 (1.85%)  0/56 (0.00%)  0/55 (0.00%)  1/20 (5.00%)  0/16 (0.00%)  1/18 (5.56%)  1/32 (3.13%)  0/35 (0.00%)  0/34 (0.00%) 
Skin lesion  1  0/54 (0.00%)  1/56 (1.79%)  1/55 (1.82%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Vascular disorders                   
Hypertension  1  0/54 (0.00%)  1/56 (1.79%)  0/55 (0.00%)  0/20 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/32 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Due to early termination of the study, Week 52 data were not available, and therefore prespecified Week 52 analyses could not be conducted.
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02520284    
Other Study ID Numbers: GS-US-326-1100
2014-005217-24 ( EudraCT Number )
First Submitted: August 7, 2015
First Posted: August 11, 2015
Results First Submitted: March 18, 2019
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019