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

Ulcerative Colitis Clinical Trial

— CAPYBARA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05479058
• Other study ID #: GLPG0634-CL-341
• Secondary ID: 2022-000719-30
• Status: Terminated
• Phase: Phase 3
• Start date: July 26, 2022
• Est. completion date: October 9, 2023

Study information

• Verified date: November 2023
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 9, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Filgotinib
Tablets administered orally once daily
• Placebo
Tablets administered orally once daily

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven Campus Gasthuisberg	Leuven
Czechia	Hepato-Gastroenterology HK	Hradec Králové
Czechia	GEP Clinic	Praha
France	CHU Amiens-Picardie	Amiens
France	Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie	Marseille
France	Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie	Nantes
France	Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition	Pessac
France	Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie	Pierre-Bénite
France	Hôpital Pontchaillou	Rennes
France	Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie	Saint-Étienne
France	Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie	Vandœuvre-lès-Nancy
Germany	DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend	Berlin
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	EUGASTRO GmbH	Leipzig
Germany	Klinikum Lüneburg	Lüneburg
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Hungary	Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet	Budapest
Hungary	Bugát Pál Kórház	Gyöngyös
Italy	IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II	Castellana Grotte
Italy	Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva	Catanzaro
Italy	Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello	Pisa
Italy	Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas	Rozzano
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital Gastroenterology	Seoul
Poland	Przychodnia Vitamed NFZ	Bydgoszcz
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Kraków
Poland	Krakowskie Centrum Medyczne	Kraków
Poland	Centrum Opieki Zdrowotnej Orkan-Med	Ksawerów
Poland	Santa Familia - Centrum Badan Profilaktyki i Leczenia	Lódz
Poland	Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski	Rzeszów
Poland	Endoskopia Sopot	Sopot
Poland	Torunskiego Centrum Gastrologii I Endoskopii - Gastromed	Torun
Poland	H-T. Centrum Medyczne Spólka z Ograniczona Odpowiedzialnoscia	Tychy
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz	Warsaw
Poland	Bodyclinic	Warszawa
Poland	Centrum Medyczne Oporów	Wroclaw
South Africa	Mediclinic Panorama	Cape Town
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Taiwan	National Taiwan University Hospital Center for Infection Control	Taipei
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Saint Helens and Knowsley Teaching Hospitals NHS Trust	Prescot
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Gastro Center of Maryland - Columbia	Columbia	Maryland
United States	University of Miami	Miami	Florida
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Rapid City Medical Center	Rapid City	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Poland,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48	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.	Week 48
Secondary	Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare	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.	Baseline (Day 1) up to 216 weeks
Secondary	Time to ES-Confirmed UC Flare	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.	Baseline (Day 1) up to 216 weeks
Secondary	Change From Baseline in C-Reactive Protein (CRP) up to Week 48		Baseline, up to Week 48
Secondary	Change From Baseline in Fecal Calprotectin (FCP) up to Week 48		Baseline, up to Week 48
Secondary	Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48	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.	Baseline, Week 48
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation		Baseline up to 216 weeks