Last updated on May 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

1.Subjects must be 18 years of age at Screening Visit 2.Subjects must have a diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled 4 criteria).

3.Subjects 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.Subjects 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.Subjects 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. Subject has a history of sensitivity to ACTH preparations or porcine products
  2. Subject has active lupus nephritis
  3. Subject has active CNS manifestations of SLE

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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