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Protocol GS-US-418-3898
Title Combined Phase 2b/3, Double-Blind, Randomized, PLACEBO-Controlled Studies Evaluating the Efficacy and Safety of FILGOTINIB in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase II/III
Area Large Intestine
Indication Moderately to Severely Active Ulcerative Colitis
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 UC of at least 6 months duration. Subject must have demonstrated an inadequate clinical response to corticosteroids, immunomodulators, TNF-á antagonists, and/or vedolizumab. There is a required 8 week washout period for any TNFá 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. There is a required 2 week washout period for any rectal compounds or antidiarrheal agents. Patients who have undergone surgical intervention (e.g., colectomy, partial colectomy, ileostomy, or colostomy) or those who will likely require surgery during the study are excluded. Study last up to 58 weeks with subjects randomized in a 1:1:1 fashion. 144 week Open Label Extension is available
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