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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

CAPYBARA Trial Summary

This trial is designed to study the efficacy of filgotinib in people who are in stable clinical remission after the dose is decreased to 100 mg.

Eligible Conditions

Ulcerative Colitis

CAPYBARA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) up to 216 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48

Secondary outcome measures

C-reactive protein

Tin

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48

+3 more

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936

Nasopharyngitis

Headache

Upper respiratory tract infection

Nausea

Bronchitis

Osteitis

Lumbar spinal stenosis

Abscess oral

Rheumatoid arthritis

Gallbladder empyema

Depression

Myocardial ischaemia

Anaemia

Vulval abscess

100%

80%

60%

40%

20%

Study treatment Arm

Filgotinib 100 mg

Placebo

Filgotinib 200 mg

CAPYBARA 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor

137 Previous Clinical Trials

22,901 Total Patients Enrolled

7 Trials studying Ulcerative Colitis

3,284 Patients Enrolled for Ulcerative Colitis

Galapagos Study DirectorStudy DirectorGalapagos NV

21 Previous Clinical Trials

13,104 Total Patients Enrolled

2 Trials studying Ulcerative Colitis

1,773 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are giving their consent to participate in this research?

"From what is published on clinicaltrials.gov, this trial is still opening to applications. The details for the study were first posted on 7/26/2022 and have since been updated on 10/24/2022. There are 3 different recruitment sites looking for a total of 80 participants."

Answered by AI

When can we expect the FDA to sign off on Filgotinib?

"There is prior clinical data supporting Filgotinib's safety, so it received a score of 3."

Answered by AI

Are patients still being enrolled in this clinical trial?

"Yes, the information available on clinicaltrials.gov suggests that this study is currently looking for participants. This trial was first posted on 7/26/2022 and has been updated as recently as 10/24/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

2022. "A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05479058.