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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: Subjects 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

Detailed Summary: This is a randomized, placebo controlled, double blind study. Following a screening period of up to 28 days, subjects 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.
Sponsor: Mallinckrodt

Current Primary Outcome: Proportion of responders assessed by the SLE Responder Index [ Time Frame: 16 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in SLE disease activity measure [ Time Frame: 16 weeks ]

Original Secondary Outcome: Same as current

Information By: Mallinckrodt

Dates:
Date Received: November 1, 2016
Date Started: October 2016
Date Completion: June 2019
Last Updated: November 2, 2016
Last Verified: November 2016