A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Participants With Active Systemic Lupus Erythematosus (SLE)



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:October 13, 2016
End Date:August 2019
Contact:Roman Bilyk, MD
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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

Participants with active systemic lupus erythematosus (SLE) will be randomized to receive
Acthar or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at
multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28
Joint Count

This is a randomized, placebo controlled, double blind study. Following a screening period of
up to 28 days, participants with active systemic lupus erythematosus (SLE) including moderate
to severe rash and/or arthritis despite corticosteroid therapy will be randomized in a 1:1
ratio to receive 1 mL (80 Units [U]) of Acthar or matching placebo. During Weeks 1 to 4, 1 mL
(80 U) of Acthar or volume matched placebo will be administered subcutaneously (SC) every
other day. For the remainder of the study (Weeks 5 to 24), Acthar 1 mL (80 U) or volume
matched placebo will be administered SC 2x/week.

Inclusion Criteria:

1. Participants must be ≥18 years of age at Screening Visit.

2. Participants must have a diagnosis of SLE according to the American College of
Rheumatology revised criteria (fulfilled ≥4 criteria).

3. Participants must have active SLE as demonstrated by a SLEDAI-2K score of ≥6 at the
Screening Visit and a clinical SLEDAI (excluding laboratory results) score ≥4 at the
Screening and Randomization Visits. Points for arthritis and/or rash must be present
at both the Screening and Randomization Visits.

4. Participants must have a documented history of positive antinuclear antibody (ANA), OR
a screening result of positive ANA, OR a documented history or positive screening
result of elevated anti-dsDNA or ENA antibodies

5. Participants must have been on prednisone (or prednisone equivalent) for ≥8 weeks
prior to the Screening Visit and on a stable dose of 7.5 mg to 30 mg of prednisone (or
prednisone equivalent) for ≥ 4 weeks prior to the Screening Visit.

Exclusion criteria:

1. Participants has a history of sensitivity to ACTH preparations or porcine products.

2. Participants has active lupus nephritis.

3. Participants has active CNS manifestations of SLE.
We found this trial at
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Middleburg Heights, Ohio 44130
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273 Bleecker Street
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