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
31
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Charlotte, North Carolina 28210
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Albuquerque, New Mexico
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Atlanta, Georgia 30342
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Ciudad Autónoma de Buenos Aires, Buenos Aires
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209 West Emery Street
Dalton, Georgia 30720
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Decatur, Georgia 30030
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Duncansville, Pennsylvania 16635
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Fort Lauderdale, Florida 33334
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Hemet, CA
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Houston, Texas 77089
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Jackson, Tennessee 38305
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Knoxville, Tennessee 37923
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Lansing, Michigan 48910
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Las Vegas, Nevada 89128
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Memphis, Tennessee 38119
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Miami, Florida 33015
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Miami, Florida 33175
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Miami Lakes, Florida 33016
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Middleburg Heights, Ohio 44130
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273 Bleecker Street
New York, New York 10014
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Oklahoma City, Oklahoma 73103
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Orangeburg, South Carolina 29118
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7912 Forest City Road
Orlando, Florida 32810
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Ormond Beach, Florida 32174
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Phoenix, Arizona 85018
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949 Calhoun Place
Riverside, California 92518
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San Antonio, Texas 78215
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