Galapagos NV, collaborating with Gilead Sciences, will soon begin recruiting for announced two new Phase 2 clinical trials to evaluate filgotinib in patients with small bowel Crohn’s disease, as well as in patients with fistulizing Crohn’s disease.
Galapagos and Gilead Sciences have a global partnership for the development and commercialization of filgotinib for inflammatory diseases.
Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1) inhibitor, an enzyme involved in the signaling pathways of several pro-inflammatory cytokines — proteins which ultimately lead to inflammation. The drug is the first JAK inhibitor to show effectiveness in Crohn’s, but it is still in investigational stages and has not been approved for any indication.
The first additional Crohn’s disease study is a Phase 2, double-blind, randomized, placebo-controlled clinical trial (NCT03046056) evaluating the effectiveness and safety of filgotinib in the treatment of small bowel Crohn’s disease (SBCD). Approximately 100 patients in North America and Europe will be randomly assigned to treatment with two doses of filgotinib or a placebo, administered for 24 weeks.
The trial’s primary endpoint is the proportion of patients achieving clinical remission after 24 weeks of treatment compared to a placebo. Clinical remission will be determined as a score below 150 in the Crohn’s Disease Activity Index (CDAI).
The second study is also a Phase 2 trial (NCT03077412). It will evaluate the effectiveness and safety of filgotinib in the treatment of perianal fistulizing Crohn’s disease. The trial is expected to enroll about 75 patients who will be randomly assigned to treatment with one of two doses of filgotinib or a placebo for 24 weeks. The trial’s primary endpoint is the proportion of patients establishing combined fistula response after 24 weeks of treatment, compared to placebo.
Eligible patients who complete either clinical trial may continue in a long-term extension study.
These new Phase 2 clinical trials evaluating filgotinib for these clinical indications follow the initiation of the DIVERSITY (NCT02914561) Phase 3 clinical trial of filgotinib in Crohn’s disease. DIVERSITY is investigating two doses of filgotinib (100 mg and 200 mg) once daily in the induction and maintenance of remission in 1,230 patients with moderate-to-severe Crohn’s disease compared to a placebo, including those with prior biological therapy failure.
In addition to the DIVERSITY trial, in 2016, Gilead initiated the FINCH Phase 3 (NCT02873936) clinical program in rheumatoid arthritis, and the SELECTION Phase 2b/3 trial (NCT02914522) in ulcerative colitis.