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Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

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: NCT02953821
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Acthar Gel
Drug: Placebo Gel
Enrollment 172
Recruitment Details  
Pre-assignment Details Of 293 who signed informed consent, 172 were randomized into treatment groups
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Period Title: Overall Study
Started 86 86
Safety Population 86 86
Modified Intent to Treat (mITT) Populati 85 84
Per Protocol (PP) Population 72 75
Completed Week 16 Visit 76 77
Completed Study Treatment (Week 24) 73 76
Completed [1] 71 73
Not Completed 15 13
Reason Not Completed
Adverse Event             0             4
Death             1             0
Progressive Disease             5             1
Lost to Follow-up             2             0
Physician Decision             1             1
Withdrawal by Subject             3             3
Change of address             0             1
Lack of Efficacy             1             0
Out of state for indeterminate time             0             1
No improvement             0             1
Refused follow-up visit             2             1
[1]
including follow-up
Arm/Group Title Placebo Gel Acthar Gel Total
Hide Arm/Group Description

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Total of all reporting groups
Overall Number of Baseline Participants 86 86 172
Hide Baseline Analysis Population Description
Safety Population (except for study-specific measures)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 172 participants
39.3  (12.99) 40.1  (12.45) 39.7  (12.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Female
82
  95.3%
76
  88.4%
158
  91.9%
Male
4
   4.7%
10
  11.6%
14
   8.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
American Indian or Alaska Native
19
  22.1%
19
  22.1%
38
  22.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   9.3%
9
  10.5%
17
   9.9%
White
30
  34.9%
33
  38.4%
63
  36.6%
More than one race
29
  33.7%
25
  29.1%
54
  31.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Physician's Global Assessment (PGA)
Hide Description PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Time Frame Baseline, Week 16, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population with score at the given week
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Overall Number of Participants Analyzed 85 84
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 85 participants 84 participants
58.8  (15.81) 60.6  (16.69)
Week 16 Number Analyzed 76 participants 77 participants
33.2  (18.77) 30.2  (14.89)
Week 24 Number Analyzed 73 participants 76 participants
26.9  (17.76) 25.5  (17.22)
2.Primary Outcome
Title British Isles Lupus Assessment Group 2004 (BILAG 2004)
Hide Description

BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new.

The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.

Time Frame Baseline, Week 16, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population with a score at the given week
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Overall Number of Participants Analyzed 85 84
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 85 participants 84 participants
18.2  (5.15) 18.0  (5.45)
Week 16 Number Analyzed 76 participants 77 participants
9.7  (6.57) 7.7  (5.91)
Week 24 Number Analyzed 73 participants 76 participants
8.0  (6.21) 6.9  (5.87)
3.Primary Outcome
Title Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
Hide Description The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
Time Frame Week 16, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent to Treat (mITT)
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Overall Number of Participants Analyzed 85 84
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16
40
  47.1%
41
  48.8%
Week 24
46
  54.1%
44
  52.4%
4.Secondary Outcome
Title Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
Hide Description Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:
Participants receive Placebo Gel
Participants receive Acthar Gel
Overall Number of Participants Analyzed 85 84
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.5%
0
   0.0%
5.Secondary Outcome
Title Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Hide Description The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement.
Time Frame at Baseline and Weeks 4, 8, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population with scores at the given week
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:
Participants receive Placebo Gel
Participants receive Acthar Gel
Overall Number of Participants Analyzed 85 84
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 84 participants 82 participants
7.1  (6.53) 7.9  (7.48)
Week 4 Number Analyzed 82 participants 81 participants
5.8  (5.57) 5.6  (5.30)
Week 8 Number Analyzed 82 participants 78 participants
5.0  (5.19) 5.0  (5.41)
Week 12 Number Analyzed 77 participants 78 participants
4.5  (5.41) 4.0  (4.08)
Week 16 Number Analyzed 75 participants 75 participants
3.8  (4.36) 3.4  (3.77)
6.Secondary Outcome
Title Mean Number of Swollen or Tender Joints on the 28-Joint Count
Hide Description The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Time Frame at Baseline and at Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population with tender and swollen joints at the given week
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:
Participants receive Placebo Gel
Participants receive Acthar Gel
Overall Number of Participants Analyzed 85 84
Overall Number of Units Analyzed
Type of Units Analyzed: Joints
28 28
Mean (Standard Deviation)
Unit of Measure: Joints
Baseline Number Analyzed 28 Joints [1]  28 Joints [2] 
7.2  (4.98) 8.2  (5.85)
Week 4 Number Analyzed 28 Joints [3]  28 Joints [2] 
4.9  (4.77) 4.2  (4.24)
Week 8 Number Analyzed 28 Joints [3]  28 Joints [4] 
3.8  (4.97) 2.9  (3.42)
Week 12 Number Analyzed 28 Joints [5]  28 Joints [4] 
2.9  (4.40) 2.3  (3.00)
Week 16 Number Analyzed 28 Joints [6]  28 Joints [6] 
2.8  (3.67) 1.9  (3.20)
[1]
84 participants
[2]
81 participants
[3]
82 participants
[4]
78 participants
[5]
77 participants
[6]
75 participants
7.Secondary Outcome
Title Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
Hide Description [Not Specified]
Time Frame Week 20, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description:
Participants receive Placebo Gel
Participants receive Acthar Gel
Overall Number of Participants Analyzed 85 84
Measure Type: Count of Participants
Unit of Measure: Participants
Week 20
5
   5.9%
3
   3.6%
Week 24
6
   7.1%
4
   4.8%
Time Frame 24 Weeks
Adverse Event Reporting Description A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
 
Arm/Group Title Placebo Gel Acthar Gel
Hide Arm/Group Description Participants receive Placebo Gel Participants receive Acthar Gel
All-Cause Mortality
Placebo Gel Acthar Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   1/86 (1.16%)      0/86 (0.00%)    
Hide Serious Adverse Events
Placebo Gel Acthar Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/86 (9.30%)      4/86 (4.65%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/86 (1.16%)  0/86 (0.00%) 
Infections and infestations     
Appendicitis  1  1/86 (1.16%)  0/86 (0.00%) 
Gastroenteritis  1  1/86 (1.16%)  0/86 (0.00%) 
Herpes zoster  1  0/86 (0.00%)  1/86 (1.16%) 
Peritonitis  1  1/86 (1.16%)  0/86 (0.00%) 
Pneumonia  1  1/86 (1.16%)  0/86 (0.00%) 
Pyelonephritis  1  1/86 (1.16%)  0/86 (0.00%) 
Soft tissue infection  1  1/86 (1.16%)  0/86 (0.00%) 
Musculoskeletal and connective tissue disorders     
Systemic lupus erythematosus  1  1/86 (1.16%)  2/86 (2.33%) 
Psychiatric disorders     
Drug abuse  1  1/86 (1.16%)  0/86 (0.00%) 
Renal and urinary disorders     
Nephrotic syndrome  1  0/86 (0.00%)  1/86 (1.16%) 
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%
Placebo Gel Acthar Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/86 (26.74%)      31/86 (36.05%)    
Infections and infestations     
Nasopharyngitis  1  6/86 (6.98%)  6 3/86 (3.49%)  3
Upper respiratory tract infection  1  1/86 (1.16%)  1 9/86 (10.47%)  10
Urinary tract infection  1  10/86 (11.63%)  13 6/86 (6.98%)  6
Nervous system disorders     
Headache  1  5/86 (5.81%)  6 6/86 (6.98%)  9
Psychiatric disorders     
Insomnia  1  4/86 (4.65%)  4 7/86 (8.14%)  7
Vascular disorders     
Hypertension  1  0/86 (0.00%)  0 6/86 (6.98%)  6
1
Term from vocabulary, MedDRA (19.1)
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 Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Call Center
Organization: Mallinckrodt
Phone: 800-556-3314 ext 5
EMail: clinicaltrials@mnk.com
Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02953821    
Other Study ID Numbers: MNK14304067
First Submitted: November 1, 2016
First Posted: November 3, 2016
Results First Submitted: July 8, 2020
Results First Posted: August 20, 2020
Last Update Posted: August 20, 2020