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

September 9, 2024 updated by: Galapagos NV

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

Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven Campus Gasthuisberg
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Hepato-Gastroenterology HK
      • Praha, Czechia, 130 00
        • GEP Clinic
  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie
      • Marseille, France, 13015
        • Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie
      • Pessac, France, 33600
        • Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Saint-Étienne, France, 42055
        • Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
      • Vandœuvre-lès-Nancy, France, 54500
        • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie
  • Germany
      • Berlin, Germany, 14050
        • DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Eugastro Gmbh
      • Lüneburg, Germany, 21339
        • Klinikum Lüneburg
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
  • Hungary
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz
  • Italy
      • Castellana Grotte, Italy, 70013
        • IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva
      • Pisa, Italy, 56124
        • Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello
      • Rozzano, Italy, 20089
        • Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System Severance Hospital Gastroenterology
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Przychodnia Vitamed NFZ
      • Kraków, Poland, 31-009
        • Gabinet Endoskopii Przewodu Pokarmowego
      • Kraków, Poland, 31-501
        • Krakowskie Centrum Medyczne
      • Ksawerów, Poland, 95-054
        • Centrum Opieki Zdrowotnej Orkan-med
      • Rzeszów, Poland, 35-302
        • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
      • Sopot, Poland, 81-756
        • Endoskopia Sopot
      • Toruń, Poland, 87-100
        • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
      • Tychy, Poland, 43-100
        • H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością
      • Warsaw, Poland, 03-580
        • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz
      • Warszawa, Poland, 03-712
        • BodyClinic
      • Wrocław, Poland, 52-416
        • Centrum Medyczne Oporow
      • Łódź, Poland, 90-302
        • Santa Familia - Centrum Badań Profilaktyki i Leczenia
  • South Africa
      • Cape Town, South Africa, 7500
        • Mediclinic Panorama
  • Spain
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital Center for Infection Control
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Norwich, United Kingdom, NR4 YUY
        • Norfolk and Norwich University Hospital
      • Prescot, United Kingdom, L35 5DR
        • Saint Helens and Knowsley Teaching Hospitals NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland - Columbia
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participants must have participated in the SELECTION-LTE study (GS-US-418-3899), who were on 200 mg filgotinib once daily and fulfilled 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;
    • fecal calprotectin (FCP) ≤250 microgram per gram (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 had a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must have agreed to continued monthly urine dipstick pregnancy testing during filgotinib treatment.
  • Female participants of childbearing potential must have agreed 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 had a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
  • Female participant who was pregnant or breastfeeding, or intended 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 was unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
  • Participant had a positive QuantiFERON® tuberculosis (TB) test at screening or had 2 indeterminate QuantiFERON® TB test results that required Investigational product (IP) treatment interruption, or participant had 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 had been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
  • Participant met discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Filgotinib 200 mg
Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.
Drug: Placebo
Administered orally once daily
Drug: Filgotinib
Administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 100 mg
Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.
Drug: Placebo
Administered orally once daily
Drug: Filgotinib
Administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
Time Frame: Week 48

The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity.

The mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0.

Corticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Time Frame: Baseline up to Week 48

PRO2 flare was 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.

PRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease.
Baseline up to Week 48
Time to ES-Confirmed UC Flare
Time Frame: Baseline up to Week 48
An ES-confirmed UC flare was 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. Each subscore graded from 0 to 3 with higher scores indicating more severe disease.
Baseline up to Week 48
Change From Baseline in C-Reactive Protein (CRP)
Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.
Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Fecal Calprotectin (FCP)
Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract.
Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time Frame: Baseline, Week 48
The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 [severe problem] to 7 [normal health]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.
Baseline, Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
Time Frame: Baseline up to Week 48

An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment.

A TEAE was defined as

  • An AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug.
  • And was either a newly reported event, or a worsening of an existing event.

Serious TEAE was defined as a TEAE that

  • Resulted in death and was life-threatening;
  • Required in-patient hospitalization or prolongation of existing hospitalization;
  • Resulted in persistent or significant disability/incapacity;
  • Was a congenital anomaly / birth defect;
  • Was medically significant.
Baseline up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Investigators

  • Study Director: Galapagos Study Director, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2022

Primary Completion (Actual)

October 9, 2023

Study Completion (Actual)

October 9, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

September 9, 2024

Last Verified

September 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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