Date: 2016-08-22
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Gilead Sciences (USA - CA) Galapagos (Belgium)
Product: GLPG0634 (filgotinib)
Action
mechanism: enzyme inhibitor/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. Galapagos and Gilead have entered into a global collaboration agreement for the development and commercialization of filgotinib for inflammatory indications.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: USA
Trial
details: (NCT01903460 )
Latest
news: * On August 22, 2016, Galapagos has reported the initiation of the FINCH global Phase 3 program investigating the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in rheumatoid arthritis (RA) patient populations, ranging from early stage to biologic-experienced patients. The FINCH program includes three studies with filgotinib. FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled study in combination with methotrexate (MTX) in an expected 1,650 patients who have had inadequate response to MTX. The primary endpoint is ACR20 at week 12. The study will also include radiographic assessment at weeks 24 and 52. * On September 25, 2015, Galapagos announced that the Company will be moving filgotinib, its highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016.
FINCH 2 is a 24-week, randomized, placebo-controlled study in an expected 423 patients who are on conventional disease-modifying anti-rheumatic drugs (cDMARD), and have had an inadequate response to biological treatment. The primary endpoint is ACR20 at week 12.
FINCH 3 is a 52-week, randomized study in an expected 1,200 MTX-naïve patients to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint is ACR20 at week 24. Radiographic progression will also be assessed.
The FINCH program in RA will be conducted in the United States and Europe to start, with other regions to follow.
* On May 24, 2016, Galapagos reported the successful completion of the discussions with the regulatory authorities in the US and Europe and discloses the doses for the FINCH global Phase 3 program with filgotinib in rheumatoid arthritis. The FINCH program will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily, globally addressing a broad RA patient population, with dosing expected to begin in Q3'16. The FINCH Phase 3 program will also contain a dedicated male patient testicular safety study.
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib for inflammatory indications. In addition to the FINCH program in RA, Gilead expects to initiate a Phase 3 study with filgotinib in Crohn's disease and a Phase 2/3 study in ulcerative colitis in Q3 '16. Interactions with the regulatory authorities in these indications are still pending and will be reported on later.
