Phase 3 Study Underway for New Class of Crohn’s Disease Medicine

Phase 3 Study Underway for New Class of Crohn’s Disease Medicine

Finding participants to enroll in a clinical trial during a pandemic is no easy feat. The good news is the completion of patient enrollment for a global Phase 3 study for a new class of Crohn’s Disease medicine. The study now underway, called DIVERSITY, will evaluate the safety and efficacy of filgotinib, a JAK1 inhibitor that performed well in the results of the Phase 2 FITZROY study in patients with active Crohn’s Disease.

In 2015, the Centers for Disease Control and Prevention (CDC) reported that 3 million adult Americans were diagnosed with Inflammatory Bowel Disease (IBD) which is the term for Crohn’s disease or ulcerative colitis. This represents about 1.3% of US adults in 2015, a big uptick from 0.9% or 2 million adults in 1999. These estimates do not include children who might have IBD because most people are diagnosed with IBD over age 20.

According to Galapagos NV, the DIVERSITY study enrolled 1,374 participants with moderately to severely active Crohn’s Disease. The study evaluates the safety and efficacy of 100mg and 200mg filgotinib versus placebo on clinical remission and endoscopic response, in a 10-week induction phase, followed by a 47-week maintenance phase.

Topline results of the DIVERSITY study are anticipated in H1 2023. Currently filgotinib is considered investigational and is not approved anywhere globally for Crohn’s Disease. However, the drug is approved and marketed as Jyseleca® in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who do not respond well to disease modifying anti-rheumatic drugs (DMARDs). Applications to extend the use of filgotinib to include ulcerative colitis have been filed in these countries while this global Phase 3 program is ongoing in Crohn’s Disease.

About The Author

Kendra Evans

Kendra Evans founded Inflammation Guide in April 2020. Our goal is keeping our readers informed to help them live an empowered and full life while they manage inflammation. Inflammation Guide provides a central location for breaking news and updates on prescriptions, treatments, supplements and alternative wellness solutions to give options to people living with at least one inflammatory condition.

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