NCT02847598

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

Conditions

• Systemic Lupus Erythematosus
• Active Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	BIIB059 (litifilimab)	Administered as specified in the treatment arm.
DRUG	Placebo	Administered as specified in the treatment arm.

Timeline

• Start date: 2016-10-20
• Primary completion: 2019-08-28
• Completion: 2019-11-18
• First posted: 2016-07-28
• Last updated: 2023-11-07
• Results posted: 2023-05-15

Locations

128 sites across 12 countries: United States, Argentina, Bulgaria, Colombia, Israel, Mexico, Philippines, Poland, Serbia, South Korea, Taiwan, Thailand

Regulatory

• FDA-regulated drug study