Galapagos, a clinical-stage biotech specializing in small molecule medicines, has dosed its first patient in its DIVERSITY (NCT02914561) Phase 3 clinical trial of filgotinib in Crohn’s disease. The trial is currently recruiting participants.
The initiation of the trial triggered a $50 million milestone payment from Gilead, the co-developer of filgotinib, a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, which ultimately lead to inflammation.
Filgotinib is the first JAK inhibitor to show effectiveness in Crohn’s, but it is still an investigational drug.
The Phase 3 trial’s primary objectives are to evaluate the drug’s effectiveness and safety in the induction and maintenance of remission in subjects with moderate-to-severe Crohn’s disease.
The DIVERSITY study will investigate two doses of filgotinib (100 mg and 200 mg) once-daily compared to a placebo in 1,230 patients, including those with prior biological therapy failure.
Participants who complete the study – or who do not meet protocol response or remission criteria at week 10 – will have the option to enter a separate long-term extension (LTE) study (NCT02914600).
“With the FITZROY Phase 2 study, Galapagos demonstrated that filgotinib has a promising efficacy and safety profile in Crohn’s disease. The start of the Phase 3 DIVERSITY study is good news for patients with Crohn’s disease,” Piet Wigerinck, PhD, chief scientific officer of Galapagos, said in a press release. “We look forward to seeing the results of DIVERSITY.”
Galapagos and Gilead have a global collaboration agreement for the development and commercialization of filgotinib in inflammatory diseases.
In addition to the DIVERSITY trial, Gilead initiated the FINCH Phase 3 (NCT02873936) clinical program in rheumatoid arthritis in August this year, and is expected to start the SELECTION Phase 2b/3 trial (NCT02914522) in ulcerative colitis later this quarter. SELECTION will involve a futility analysis, which will serve as the Phase 2b part of the study.
Both DIVERSITY and SELECTION will recruit participants from the United States, Europe, Latin America, Canada and Asia/Pacific. In the U.S., men will be treated with 200 mg of filgotinib if they failed at least one anti-TNF (tumor necrosis factor) and Entyvio (vedolizumab). Testicular safety analyses will be included.
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