Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Study Overview
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Brief Summary
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This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: Acthar Gel Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: see how well the gel is working see how safe it is for patients with SLE

Detailed Description
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This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Official Title
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A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: Acthar Gel
* Drug: Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible to participate in this trial, a patient must: Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria Have active SLE Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits Have a documented history or screening result of positive antinuclear antibody (ANA), OR elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies Have been on prednisone (or prednisone equivalent) before the screening visit: at least 8 weeks, and at a stable dose of 7.5 mg to 30 mg for at least 4 weeks Exclusion criteria: A patient is not eligible to participate if he/she: Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products Has active lupus nephritis Has active central nervous system (CNS) manifestations of SLE

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acthar Gel<br>Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks | Drug: Acthar Gel<br>* 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)<br>* Other names: Repository corticotropin;|
| Placebo Comparator: Placebo Gel<br>Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks | Drug: Placebo Gel<br>* 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)<br>* Other names: Matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment (PGA) | PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement. | Baseline, Week 16, Week 24 | 
| British Isles Lupus Assessment Group 2004 (BILAG 2004) | 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. | Baseline, Week 16, Week 24 | 
| Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) | 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. | Week 16, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 | 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. | Week 16 | 
| Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score | 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. | at Baseline and Weeks 4, 8, and 16 | 
| Mean Number of Swollen or Tender Joints on the 28-Joint Count | 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. | at Baseline and at Weeks 4, 8, 12 and 16 | 
| Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 |  | Week 20, Week 24 |