Galapagos initiates phase 3 trial of filgotinib in Crohn's disease

The first patient has been dosed in the phase 3 DIVERSITY trial of filgotinib in Crohn’s disease, according to a press release from the drugmaker.

Filgotinib (Galapagos) is an oral, selective Janus kinase 1 (JAK1) inhibitor previously shown to benefit patients with rheumatoid arthritis in the DARWIN trials, and patients with Crohn’s disease in the FITZROY trial.

“With the FITZROY phase 2 study, Galapagos demonstrated that filgotinib has a promising efficacy and safety profile in Crohn’s disease,” Piet Wigerinck, MD, CSO of Galapagos, said in the press release. “The start of the phase 3 DIVERSITY study is good news for patients with Crohn’s disease.”

This global study will evaluate the efficacy and safety of once-daily filgotinib at 100-mg and 200-mg doses compared with placebo in 1,320 patients with moderate-to-severe active Crohn’s disease, including patients for whom previous treatment with biologics failed.

The study’s commencement has also initiated a $50 million milestone payment from Gilead as part of the companies’ global collaboration on the development and commercialization of filgotinib. Gilead also initiated the phase 3 FINCH program in rheumatoid arthritis in August 2016, and anticipates the phase 2b/3 SELECTION study in ulcerative colitis will begin later this quarter, according to the press release.

Disclosures: Wigerinck is employed by Galapagos.