Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE).

The doctor will assign eligible patients to one of two groups (like flipping a coin).

Participants will receive the treatment assigned to their group for 24 weeks:

• Acthar Gel
• Placebo Gel, which looks like Acthar Gel, but has no medicine in it.

The doctor or his staff will take measurements and ask questions to:

• see how well the gel is working
• see how safe it is for patients with SLE

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Inclusion Criteria:

To be eligible to participate in this trial, a patient must:

• Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria

• Have active SLE

• Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits

• Have a documented history or screening result of

  1. positive antinuclear antibody (ANA), OR
  2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies

• Have been on prednisone (or prednisone equivalent) before the screening visit:

  1. at least 8 weeks, and
  2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

Exclusion criteria:

A patient is not eligible to participate if he/she:

• Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
• Has active lupus nephritis
• Has active central nervous system (CNS) manifestations of SLE