Date: 2017-03-10
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Galapagos (Belgium) Gilead Sciences (USA - CA)
Product: filgotinib
Action
mechanism: janus 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.
Disease: fistulizing Crohn's disease
Therapeutic
area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases
Country:
Trial
details:
Latest
news:
- • On March 10, 2017 ,Galapagos announce two new Phase 2 studies investigating filgotinib in small bowel Crohn's disease as well as in fistulizing Crohn's disease. These studies are being led by filgotinib collaboration partner Gilead Sciences. The second Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with perianal fistulizing Crohn's disease. Approximately 75 patients are planned to be randomized in the study to receive one of two doses of filgotinib or placebo administered for 24 weeks. The primary objective is to evaluate the efficacy of filgotinib, compared to placebo, in establishing a combined fistula response at week 24.
Eligible patients who complete either study may be able to continue in a long term extension study.
These new Phase 2 studies with filgotinib follow the initiation of the DIVERSITY Phase 3 study in Crohn's disease. Gilead further initiated the FINCH Phase 3 program in rheumatoid arthritis and the SELECTION Phase 2b/3 study in ulcerative colitis in 2016.
Is
general: Yes
