Date: 2017-04-25
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Galapagos (Belgium)
Product: filgotinib and GS-9876
Action mechanism: janus kinase inhibitor/Syk kinase inhibitor. Filgotinib is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. Filgotinib differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. GS-9876 is a Spleen Tyrosine Kinase (SYK) inhibitor. This enzyme mediates immunoreceptor signaling in a range of hematopoietic cells important for the initiation and progression of inflammatory diseases such as rheumatoid arthritis and other autoimmune diseases including B lymphocytes, monocytes, macrophages, dendritic cells, and osteoclasts.
Disease: cutaneous lupus erythematosus
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Dermatological diseases
Country:
Trial details: The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
Latest news: • On April 25, 2017, Galapagos announced a new Phase 2 Proof-of-Concept study investigating filgotinib and another investigational agent in cutaneous lupus erythematosus. This study is being led by filgotinib collaboration partner Gilead Sciences. 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. The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled study in adult female patients with active cutaneous lupus erythematosus. 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.
