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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02953821
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mallinckrodt
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julie Zhu
Principal Investigator Affiliation	Mallinckrodt
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Chile, Colombia, Mexico, Peru, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic

Additional Details

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.

Arms & Interventions

Arms

Experimental: Repository corticotropin injection

During Weeks 1 to 4, 1 mL (80 U) of repository corticotropin injection will be administered subcutaneously (SC) every other day. During Weeks 5 to 24, repository corticotropin injection 1 mL (80 U) will be administered SC 2x/week.

Placebo Comparator: Placebo gel

During Weeks 1 to 4, 1 mL of Placebo gel will be administered subcutaneously (SC) every other day. During Weeks 5 to 24, Placebo gel 1 mL will be administered SC 2x/week.

Interventions

Drug: - Repository corticotropin injection

Drug: - Placebo gel

Contact a Trial Team

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Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Research

Mesa, Arizona, 85202

Site Contact

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