← Back to Search

Janus Kinase (JAK) Inhibitor

Filgotinib for Colitis (CAPYBARA Trial)

Phase 3
Waitlist Available
Research Sponsored by Galapagos NV
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 baseline, week 4, week 12, week 24, week 36, and week 48
Awards & highlights
Pivotal Trial

Summary

This trial is studying whether patients who are doing well on a higher dose of filgotinib can maintain their remission with a reduced dose. Filgotinib helps reduce inflammation, which is key to keeping these patients in remission.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 12, week 24, week 36, and week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 12, week 24, week 36, and week 48 for reporting.

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 in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
Secondary study objectives
Change From Baseline in C-Reactive Protein (CRP)
Change From Baseline in Fecal Calprotectin (FCP)
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
+3 more

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936
6%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Headache
5%
Nausea
2%
Bronchitis
1%
Gallbladder empyema
1%
Anaemia
1%
Myocardial ischaemia
1%
Abscess oral
1%
Vulval abscess
1%
Lumbar spinal stenosis
1%
Osteitis
1%
Depression
1%
Rheumatoid arthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Filgotinib 100 mg
Placebo
Filgotinib 200 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Filgotinib 200 mgExperimental Treatment2 Interventions
Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.
Group II: Filgotinib 100 mgExperimental Treatment2 Interventions
Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Filgotinib
2017
Completed Phase 3
~7520

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor
139 Previous Clinical Trials
23,470 Total Patients Enrolled
8 Trials studying Colitis
3,344 Patients Enrolled for Colitis
Galapagos Study DirectorStudy DirectorGalapagos NV
24 Previous Clinical Trials
13,739 Total Patients Enrolled
2 Trials studying Colitis
1,773 Patients Enrolled for Colitis
~7 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top