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Protocol GS-US-419-3895
Title Combined Phase 3, Double-Blind, Randomized, PLACEBO-Controlled Studies Evaluating the Efficacy and Safety of FILGOTINIB in the Induction and Maintenance of Remission in Subjects with Moderate to Severely Active Crohn’s Disease
Phase III
Area GI
Indication Moderate to Severely Active Crohn’s Disease
Treatment Filgotinib (GS-6034, formerly known as GLPG0634) is a potent and selective inhibitor of Janus kinase 1 (JAK1). JAK inhibitors block the signaling of various cytokines, growth factors, and hormones, including the pro-inflammatory cytokine interleukin (IL)-6. Inhibition of JAKs is a promising therapeutic option for a range of inflammatory conditions including rheumatoid arthritis (RA) and Crohn’s Disease
Requirement The subject population consists of men or women 18 to 75 years of age with documented diagnosis of Crohn’s disease of at least 6 months duration. Both TNFα antagonist experienced and naïve subjects are permitted within the study. There is a required 8 week washout period for any TNFα antagonists, integrin antagonists, and any other investigational biologic agent. There is a required 30 day washout period for corticosteroids with a dose equivalent to >30mg/day as well as infliximab, adalimumab, golimumab, certolizumab, or other biosimilar agents. Patients with current complications such as symptomatic strictures, severe impassable rectal/anal stenosis, fistulae, or short bowel syndrome are prohibited. Study lasts up to 58 weeks with subjects randomized in a 1:1:1 ratio. 144 week Open Label Extension is available
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