Date: 2016-11-22
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Gilead Sciences (USA - CA) Galapagos (Belgium)
Product: filgotinib
Action
mechanism: janus kinase inhibitor.GLPG0634 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. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. In December 2015, Galapagos and Gilead entered into a global partnership for the development and commercialization of filgotinib for inflammatory indications for the development and commercialization of filgotinib for inflammatory indications.
Disease: Crohn's disease
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: USA
Trial
details: The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896). (NCT02914561)
Latest
news: * On November 22, 2016, Galapagos reported the first dosing of a patient in the DIVERSITY Phase 3 study with filgotinib in Crohn's disease (CD). The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure.
* On September 27, 2016, Galapagos reported the successful completion of discussions with the regulatory authorities in the US and Europe to initiate the DIVERSITY Phase 3 study in Crohn's disease and the SELECTION Phase 2b/3 study in ulcerative colitis with filgotinib. Both studies will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderately to severely active disease including those with prior antibody therapy failure. First dosing is expected in Q4'16.
Both studies will recruit approximately 1,300 patients each from the US, Europe, Latin America, Canada, and Asia/Pacific. The SELECTION Phase 2b/3 study in ulcerative colitis will include a futility analysis, serving as the Phase 2b part of this integrated Phase 2b/3 study. Men and women in both the SELECTION and DIVERSITY studies will be randomized to receive placebo, 100 mg or 200 mg filgotinib. In the US, males may receive 200 mg if they failed at least one anti-TNF and vedolizumab[1]. The filgotinib Phase 3 program will also contain a dedicated male patient testicular safety study.
