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Janus kinase (JAK) inhibitor
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) (DIVERGENCE 1 Trial)
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
All Individual Drugs Already Approved
Summary
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.
Eligible Conditions
- Crohn's disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieved Clinical Remission at Week 24
Secondary study objectives
Change From Baseline in CDAI Scores at Week 10
Change From Baseline in CDAI Scores at Week 24
Ileum
+11 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Filgotinib 200 mgExperimental Treatment2 Interventions
Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.
Group II: Filgotinib 100 mgExperimental Treatment2 Interventions
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.
Group III: PlaceboPlacebo Group1 Intervention
PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to match filgotinib
2016
Completed Phase 3
~3600
Filgotinib
FDA approved
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,137 Previous Clinical Trials
867,821 Total Patients Enrolled
Galapagos NVIndustry Sponsor
139 Previous Clinical Trials
23,414 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
361 Previous Clinical Trials
192,205 Total Patients Enrolled