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

Not Applicable

Recruiting

• Conditions: -M329 Systemic lupus erythematosus, unspecified; Systemic lupus erythematosus, unspecified; M329

• Registration Number: PER-005-17
• Lead Sponsor: Mallinckrodt ARD Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Study Completion: 2019-10-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Male or nonpregnant, nonlactating female subjects 18 years of age or older with a diagnosis of SLE according
to the American College of Rheumatology revised criteria (fulfilled ≥ 4 criteria) and active disease defined as
total SLEDAI-2K score ≥ 6 and clinical SLEDAI-2K (excluding laboratory domains) score of ≥ 4 at the time of
screening and randomization (points for arthritis and/or rash must be present at both screening and randomization), and a BILAG-2004 score of A or B in the in the mucocutaneous and/or musculoskeletal body
systems at screening and randomization. Subjects must have documented history of a positive antinuclear
antibody and autoantibodies to at least 1 of the following: anti-dsDNA, anti-Smith, or anti-cardiolipin. Subjects
with Type 1 or Type 2 diabetes, active central nervous system manifestations of SLE or active lupus nephritis,
tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for Acthar will be
excluded. Subjects must exhibit disease activity despite being on a stable daily dose of a corticosteroid (7.5 mg
to 30 mg per day [inclusive] of prednisone or prednisone equivalent) for at least 4 weeks prior to the Screening
Visit. Subjects may be taking antimalarials and nonsteroidal anti-inflammatory drugs if they are on a stable dose for at
least 4 weeks prior to the Screening Visit and will remain on that dose throughout the study.

Exclusion Criteria

Subject is from a vulnerable population, as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB/IEC. Subject has a history of sensitivity to ACTH preparations (including but not limited to
Acthar and Synacthen). Subject has a history of sensitivity to porcine protein products.
Subject has severe active lupus nephritis defined as serum creatinine > 2.5 mg/dL or
protein creatinine ratio > 1.5 g/g, or subject has required hemodialysis within 3 months
prior to the screening visit or is likely to require hemodialysis throughout the study.
Subject has active CNS manifestations of lupus (as evidenced by seizures, psychoses,
organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) within the 3 months prior to the Screening Visit or develops CNS lupus between the Screening Visit and the first dose of study drug. Subject has Type 1 or Type 2 diabetes mellitus or is taking hypoglycemic medication (a history of gestational diabetes mellitus is not exclusionary). Subjects must not have
glycosylated hemoglobin (HbA1c)> 6.5 at the Screening Visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified