Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
(DIVERSITY1 Trial)

Recruiting in Palo Alto (17 mi)

+517 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Galapagos NV

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Research Team

Galapagos Study Director

Principal Investigator

Galapagos NV

Eligibility Criteria

Inclusion Criteria

Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit

Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment

Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators

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Treatment Details

Interventions

Filgotinib (Janus Kinase (JAK) Inhibitor)

Participant Groups

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Filgotinib 200 mg to Placebo (Maintenance Study)Experimental Treatment2 Interventions

Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

Group II: Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)Experimental Treatment1 Intervention

Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

Group III: Filgotinib 100 mg to Placebo (Maintenance Study)Experimental Treatment2 Interventions

Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

Group IV: Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)Experimental Treatment1 Intervention

Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

Group V: Cohort B: Filgotinib 200 mg (Induction Study)Experimental Treatment2 Interventions

Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Group VI: Cohort B: Filgotinib 100 mg (Induction Study)Experimental Treatment2 Interventions

Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

Group VII: Cohort A: Filgotinib 200 (mg) (Induction Study)Experimental Treatment2 Interventions

Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Group VIII: Cohort A: Filgotinib 100 mg (Induction Study)Experimental Treatment2 Interventions

Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

Group IX: Placebo to Placebo (Maintenance Study)Placebo Group1 Intervention

Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

Group X: Cohort B: Placebo (Induction Study)Placebo Group2 Interventions

Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Group XI: Cohort A: Placebo (Induction Study)Placebo Group2 Interventions

Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.