NCT02953821

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Acthar Gel	1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
DRUG	Placebo Gel	1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Timeline

• Start date: 2016-12-16
• Primary completion: 2019-07-31
• Completion: 2019-10-25
• First posted: 2016-11-03
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

39 sites across 5 countries: United States, Argentina, Chile, Mexico, Peru

Regulatory

• FDA-regulated drug study