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Janus Kinase (JAK) Inhibitor

Filgotinib for Ulcerative 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 (day 1) up to 216 weeks
Awards & highlights

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
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) up to 216 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) up to 216 weeks 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) at Week 48
Secondary study objectives
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48
Time to ES-Confirmed UC Flare
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Filgotinib 200 mgExperimental Treatment2 Interventions
Participants will receive filgotinib 200 mg and placebo to match filgotinib 100 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with endoscopic score (ES)-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study. Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 200 mg q.d. The maximum duration of the treatment will be 216 weeks.
Group II: Filgotinib 100 mgExperimental Treatment2 Interventions
Participants will receive filgotinib 100 mg and placebo to match filgotinib 200 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study. Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 100 mg q.d. The maximum duration of the treatment will be 216 weeks.
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
138 Previous Clinical Trials
22,924 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,284 Patients Enrolled for Ulcerative Colitis
Galapagos Study DirectorStudy DirectorGalapagos NV
23 Previous Clinical Trials
13,193 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
1,773 Patients Enrolled for Ulcerative Colitis
~7 spots leftby Oct 2025
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