Galapagos announces a new Phase 2 Proof-of-Concept study investigating filgotinib and another investigational agent in cutaneous lupus erythematosus (CLE). This study is being led by filgotinib collaboration partner Gilead Sciences, Inc.
“We are very excited with the initiation of this Proof-of-Concept study with filgotinib in CLE. This is the first time we evaluate filgotinib in an autoimmune skin disorder, and specifically, one with a significant unmet need,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “This study represents another cornerstone in Gilead and Galapagos’ efforts to explore filgotinib in inflammation. We look forward to seeing whether filgotinib can impact signs and symptoms of CLE.”
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. This study in CLE is in addition to the ongoing Phase 2 studies in Sjögren’s syndrome, ankylosing spondylitis (TORTUGA), and psoriatic arthritis (EQUATOR), as well as the ongoing FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 study in Crohn’s disease (also Phase 2 in small bowel and fistulizing Crohn’s disease), and the SELECTION Phase 2b/3 study in ulcerative colitis.
Filgotinib in CLE
The Phase 2 study will be a multi-center, randomized, double-blind, placebo-controlled study in adult female patients with active CLE. Approximately 50 patients are planned to be randomized in 18 centers in the US and Canada to receive either filgotinib, another investigational drug or placebo, administered once daily. The primary endpoint will be change the change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at Week 12.
Lupus is an autoimmune disease affecting multiple organs and systems in the body, resulting in a wide variety of signs and symptoms. CLE is a form of lupus in the skin which can be triggered or exacerbated by exposure to sunlight. CLE is most commonly diagnosed in women 20-50 years of age, although it may occur at any age. Approximately 1/3 of women who are diagnosed with CLE also develop systemic lupus erythematosus (SLE). Overall, therapeutic options for CLE are limited, and there are limited clinical trial data in CLE for the biologic and synthetic DMARDs that have been approved for other indications.
