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

Last updated: September 9, 2024
Sponsor: Galapagos NV
Overall Status: Terminated

Phase

3

Condition

Colic

Ulcers

Bowel Dysfunction

Treatment

Placebo

Filgotinib

Clinical Study ID

NCT05479058
GLPG0634-CL-341
2022-000719-30
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants must have participated in the SELECTION-LTE study (GS-US-418-3899), whowere on 200 mg filgotinib once daily and fulfilled the following conditions:

  • partial Mayo Clinical Score remission over a period of at least 2 consecutivequarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to screeningof 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 observationwithin 6 months prior to screening or FCP ≤250 μg/g during the screening of thepresent study.

  • sigmoidoscopy ES of 0 or 1 (local score) at screening.

  • Willing to refrain from live attenuated vaccines during the study and for 12 weeksafter the last dose of filgotinib in the study.

  • Female participants of childbearing potential must have had a negative highlysensitive (serum beta human chorionic gonadotropin) pregnancy test during screeningand must have agreed to continued monthly urine dipstick pregnancy testing duringfilgotinib treatment.

  • Female participants of childbearing potential must have agreed to use highlyeffective contraception measures as defined in the protocol.

Exclusion

Key Exclusion Criteria:

  • Any chronic medical condition (including but not limited to, cardiac or pulmonarydisease, alcohol, or drug abuse) that, in the opinion of the investigator orsponsor, would make the participant unsuitable for the study or would preventcompliance with the study protocol.

  • Participant had a known hypersensitivity to filgotinib ingredients or history of asignificant allergic reaction to filgotinib ingredients as determined by theinvestigator.

  • Female participant who was pregnant or breastfeeding, or intended to become pregnantor breastfeed, and/or plans to undergo egg donation or egg harvesting for thepurpose of current or future fertilization, during the study and until the end ofthe study.

  • Participant was unable or unwilling to comply with restrictions regarding prior andconcomitant medication as described in the protocol.

  • Participant had a positive QuantiFERON® tuberculosis (TB) test at screening or had 2indeterminate QuantiFERON® TB test results that required Investigational product (IP) treatment interruption, or participant had sign and symptoms of TB reactivationat screening.

  • History of malignancy during or in the last 5 years prior to participation in the UCparent studies, except for participants who had been successfully treated fornonmelanoma 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 Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 26, 2022
Estimated Completion Date:
October 09, 2023

Study 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.

Connect with a study center

  • Universitair Ziekenhuis Leuven Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Hepato-Gastroenterology HK

    Hradec Králové, 500 12
    Czechia

    Site Not Available

  • GEP Clinic

    Praha, 130 00
    Czechia

    Site Not Available

  • CHU Amiens-Picardie

    Amiens, 80054
    France

    Site Not Available

  • Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie

    Marseille, 13015
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie

    Nantes, 44000
    France

    Site Not Available

  • Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition

    Pessac, 33600
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

    Saint-Étienne, 42055
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend

    Berlin, 14050
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • EUGASTRO GmbH

    Leipzig, 04103
    Germany

    Site Not Available

  • Klinikum Lüneburg

    Lüneburg, 21339
    Germany

    Site Not Available

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423
    Germany

    Site Not Available

  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

    Budapest, 1097
    Hungary

    Site Not Available

  • Bugát Pál Kórház

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II

    Castellana Grotte, 70013
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva

    Catanzaro, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello

    Pisa, 56124
    Italy

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System Severance Hospital Gastroenterology

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Przychodnia Vitamed NFZ

    Bydgoszcz, 85-079
    Poland

    Site Not Available

  • Gabinet Endoskopii Przewodu Pokarmowego

    Kraków, 31-009
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne

    Kraków, 31-501
    Poland

    Site Not Available

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054
    Poland

    Site Not Available

  • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

    Rzeszów, 35-302
    Poland

    Site Not Available

  • Endoskopia Sopot

    Sopot, 81-756
    Poland

    Site Not Available

  • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

    Toruń, 87-100
    Poland

    Site Not Available

  • H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością

    Tychy, 43-100
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz

    Warsaw, 03-580
    Poland

    Site Not Available

  • Bodyclinic

    Warszawa, 03-712
    Poland

    Site Not Available

  • Centrum Medyczne Oporów

    Wrocław, 52-416
    Poland

    Site Not Available

  • Santa Familia - Centrum Badań Profilaktyki i Leczenia

    Łódź, 90-302
    Poland

    Site Not Available

  • Mediclinic Panorama

    Cape Town, 7500
    South Africa

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • National Taiwan University Hospital Center for Infection Control

    Taipei, 10002
    Taiwan

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, NR4 YUY
    United Kingdom

    Site Not Available

  • Saint Helens and Knowsley Teaching Hospitals NHS Trust

    Prescot, L35 5DR
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Gastro Center of Maryland - Columbia

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Rapid City Medical Center

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

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