Galapagos + Gilead initiate a three Phase III trial program for filgotinib, once daily, in rheumatoid arthritis .

Galapagos NV reports the initiation of the FINCH global Phase III 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 ACR201 at week 12. The study will also include radiographic assessment at weeks 24 and 52. 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-na�ve 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.

Comment: Galapagos and Gilead have entered into a global collaboration for the development and commercialization of filgotinib for inflammatory indications.