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

This is a randomized, placebo controlled, double blind study. Following a screening period of
up to 28 days, participants 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.

Inclusion Criteria:

1. Participants must be ≥18 years of age at Screening Visit.

2. Participants must have a diagnosis of SLE according to the American College of
Rheumatology revised criteria (fulfilled ≥4 criteria).

3. Participants 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. Participants 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. Participants 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. Participants has a history of sensitivity to ACTH preparations or porcine products.

2. Participants has active lupus nephritis.

3. Participants has active CNS manifestations of SLE.