- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479058
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission (CAPYBARA)
A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Galapagos Medical Information
- Phone Number: +3215342900
- Email: medicalinfo@glpg.com
Study Locations
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Leuven, Belgium, 3000
- Universitair Ziekenhuis Leuven Campus Gasthuisberg
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Hradec Králové, Czechia, 500 12
- Hepato-Gastroenterology HK
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Praha, Czechia, 130 00
- GEP Clinic
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Amiens, France, 80054
- CHU Amiens-Picardie
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Marseille, France, 13015
- Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
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Nantes, France, 44000
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie
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Pessac, France, 33600
- Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition
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Pierre-Bénite, France, 69495
- Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie
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Rennes, France, 35033
- Hôpital Pontchaillou
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Saint-Étienne, France, 42055
- Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
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Vandœuvre-lès-Nancy, France, 54500
- Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie
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Berlin, Germany, 14050
- DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend
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Kiel, Germany, 24105
- Universitatsklinikum Schleswig-Holstein
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Leipzig, Germany, 04103
- Eugastro GmbH
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Lüneburg, Germany, 21339
- Klinikum Luneburg
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Minden, Germany, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
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Budapest, Hungary, 1097
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
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Gyöngyös, Hungary, 3200
- Bugat Pal Korhaz
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Castellana Grotte, Italy, 70013
- IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II
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Catanzaro, Italy, 88100
- Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva
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Pisa, Italy, 56124
- Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello
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Rozzano, Italy, 20089
- Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
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Daegu, Korea, Republic of, 42415
- Yeungnam University Medical Center
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Seoul, Korea, Republic of, 02447
- Kyung Hee University Hospital
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Seoul, Korea, Republic of, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea, Republic of, 03722
- Yonsei University Health System Severance Hospital Gastroenterology
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Bydgoszcz, Poland, 85-079
- Przychodnia Vitamed NFZ
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Kraków, Poland, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
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Kraków, Poland, 31-501
- Krakowskie Centrum Medyczne
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Ksawerów, Poland, 95-054
- Centrum Opieki Zdrowotnej Orkan-Med
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Rzeszów, Poland, 35-302
- Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
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Sopot, Poland, 81-756
- Endoskopia Sopot
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Toruń, Poland, 87-100
- Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
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Tychy, Poland, 43-100
- H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością
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Warsaw, Poland, 03-580
- Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
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Warszawa, Poland, 03-712
- BodyClinic
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Wrocław, Poland, 52-416
- Centrum Medyczne Oporow
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Łódź, Poland, 90-302
- Santa Familia - Centrum Badań Profilaktyki i Leczenia
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Cape Town, South Africa, 7500
- Mediclinic Panorama
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Taipei, Taiwan, 10002
- National Taiwan University Hospital Center for Infection Control
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Cambridge, United Kingdom, CB2 0QQ
- Addenbrooke's Hospital
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Norwich, United Kingdom, NR4 YUY
- Norfolk and Norwich University Hospital
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Prescot, United Kingdom, L35 5DR
- Saint Helens and Knowsley Teaching Hospitals NHS Trust
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Southampton, United Kingdom, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Naples, Florida, United States, 34102
- Gastroenterology Group Of Naples
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Maryland
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Columbia, Maryland, United States, 21045
- Gastro Center of Maryland - Columbia
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Rapid City Medical Center
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Virginia
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Chesapeake, Virginia, United States, 23320
- Gastroenterology Associates of Tidewater
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
Participants must be participating in the SELECTION-LTE study (GS-US-418-3899), currently on 200 mg filgotinib q.d. and fulfill the following conditions:
- partial Mayo Clinical Score remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to screening of the present study;
- free of corticosteroids for at least 12 weeks prior to and including baseline;
- FCP ≤250 μg/g at last observation within 6 months prior to screening or FCP ≤250 μg/g during the screening of the present study.
- sigmoidoscopy ES of 0 or 1 (local score) at screening.
- Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of filgotinib in the study.
- Female participants of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during filgotinib treatment.
- Female participants of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
Key Exclusion Criteria:
- Any chronic medical condition (including but not limited to, cardiac or pulmonary disease, alcohol, or drug abuse) that, in the opinion of the investigator or sponsor, would make the participant unsuitable for the study or would prevent compliance with the study protocol.
- Participant has a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
- Female participant who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and/or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.
- Participant is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
- Participant has a positive QuantiFERON® tuberculosis (TB) test at screening or has 2 indeterminate QuantiFERON® TB test results that require IP treatment interruption, or participant has sign and symptoms of TB reactivation at screening.
- History of malignancy during or in the last 5 years prior to participation in the UC parent studies, except for participants who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
- Participant meets discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Filgotinib 200 mg
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. |
Tablets administered orally once daily
Other Names:
Tablets administered orally once daily
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Experimental: Filgotinib 100 mg
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. |
Tablets administered orally once daily
Other Names:
Tablets administered orally once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
Time Frame: Week 48
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mMCS score is composed of subscores from rectal bleeding, stool frequency, and endoscopic findings (the range of each subscore is 0 to 3 with higher score indicating severe disease).
mMCS remission is defined as mMCS score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0.
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Week 48
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Time Frame: Baseline (Day 1) up to 216 weeks
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PRO2 includes items of stool frequency and rectal bleeding.
The range of each item score is 0 to 3 with higher score indicating severe disease.
PRO2 flare is defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1.
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Baseline (Day 1) up to 216 weeks
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Time to ES-Confirmed UC Flare
Time Frame: Baseline (Day 1) up to 216 weeks
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An ES-confirmed UC flare is defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point.
The range of each item score is 0 to 3 with higher score indicating severe disease.
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Baseline (Day 1) up to 216 weeks
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Change From Baseline in C-Reactive Protein (CRP) up to Week 48
Time Frame: Baseline, up to Week 48
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Baseline, up to Week 48
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Change From Baseline in Fecal Calprotectin (FCP) up to Week 48
Time Frame: Baseline, up to Week 48
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Baseline, up to Week 48
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48
Time Frame: Baseline, Week 48
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IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items).
Every question has graded responses from 1 (worst situation) to 7 (best situation).
The total score is the sum of the score from each question and ranges from 32 to 224 with higher scores representing better quality of life.
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Baseline, Week 48
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation
Time Frame: Baseline up to 216 weeks
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Baseline up to 216 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Galapagos Study Director, Galapagos NV
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLPG0634-CL-341
- 2022-000719-30 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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