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

Mallinckrodt ARD Inc,0 个研究点目标入组 17 人开始时间: 2017年7月10日最近更新: 2023年9月4日

适应症

试验速览

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•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.

•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.

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