Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Mallinckrodt

Status and phase: Completed; Phase 4

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Placebo Gel; Drug: Acthar Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02953821

MNK14304067

Details and patient eligibility

About

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

Full description

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

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 2 patient groups, including a placebo group

Acthar Gel

Experimental group

Description:

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Treatment:

Drug: Acthar Gel

Placebo Gel

Placebo Comparator group

Description:

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Treatment:

Drug: Placebo Gel