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

NCT05479058 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: GLPG0634-CL-3412022-000719-30
• Study Type: interventional
• Target: 22
• Locations: 13 countries
• Sites: 50

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (6)

• Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare

  Baseline up to Week 48

• Time to ES-Confirmed UC Flare

  Baseline up to Week 48

• Change From Baseline in C-Reactive Protein (CRP)

  Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48

• Change From Baseline in Fecal Calprotectin (FCP)

  Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48

• Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score

  Baseline, Week 48

Study Arms (2)

Filgotinib 200 mg

EXPERIMENTAL

Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.

Drug: Filgotinib; Drug: Placebo

Filgotinib 100 mg

EXPERIMENTAL

Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.

Drug: Filgotinib; Drug: Placebo

Interventions

Filgotinib DRUG

Administered orally once daily

Also known as: GS-6034, GLPG0634

Filgotinib 100 mg; Filgotinib 200 mg

Placebo DRUG

Administered orally once daily

Filgotinib 100 mg; Filgotinib 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (50)

University of Miami

Miami, Florida, 33136, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Gastro Center of Maryland - Columbia

Columbia, Maryland, 21045, United States

Location

Rapid City Medical Center

Rapid City, South Dakota, 57701, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Universitair Ziekenhuis Leuven Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Hepato-Gastroenterology HK

Hradec Králové, 500 12, Czechia

Location

GEP Clinic

Prague, 130 00, Czechia

Location

CHU Amiens-Picardie

Amiens, 80054, France

Location

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

Marseille, 13015, France

Location

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

Nantes, 44000, France

Location

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

Pessac, 33600, France

Location

Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie

Pierre-Bénite, 69495, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

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

Saint-Etienne, 42055, France

Location

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

Vandœuvre-lès-Nancy, 54500, France

Location

DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend

Berlin, 14050, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

EUGASTRO GmbH

Leipzig, 04103, Germany

Location

Klinikum Lüneburg

Lüneburg, 21339, Germany

Location

Gastroenterologische Gemeinschaftspraxis Minden

Minden, 32423, Germany

Location

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

Budapest, 1097, Hungary

Location

Bugát Pál Kórház

Gyöngyös, 3200, Hungary

Location

IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II

Castellana Grotte, 70013, Italy

Location

Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva

Catanzaro, 88100, Italy

Location

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

Pisa, 56124, Italy

Location

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

Rozzano, 20089, Italy

Location

Przychodnia Vitamed NFZ

Bydgoszcz, 85-079, Poland

Location

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, 31-009, Poland

Location

Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Centrum Opieki Zdrowotnej Orkan-Med

Ksawerów, 95-054, Poland

Location

Santa Familia - Centrum Badań Profilaktyki i Leczenia

Lodz, 90-302, Poland

Location

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

Rzeszów, 35-302, Poland

Location

Endoskopia Sopot

Sopot, 81-756, Poland

Location

Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

Torun, 87-100, Poland

Location

H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością

Tychy, 43-100, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz

Warsaw, 03-580, Poland

Location

Bodyclinic

Warsaw, 03-712, Poland

Location

Centrum Medyczne Oporów

Wroclaw, 52-416, Poland

Location

Mediclinic Panorama

Cape Town, 7500, South Africa

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Yonsei University Health System Severance Hospital Gastroenterology

Seoul, 03722, South Korea

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

National Taiwan University Hospital Center for Infection Control

Taipei, 10002, Taiwan

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 YUY, United Kingdom

Location

Saint Helens and Knowsley Teaching Hospitals NHS Trust

Prescot, L35 5DR, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

This study was terminated as the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation.

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos N.V.

medicalinfo@glpg.com

+32 15 342 900

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was double-blinded to treatment assignment until the last subject has reached the primary analysis time point.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: July 26, 2022
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4); DE (5); ZA (1); ES (1); GB (4); PL (12); CZ (2); TW (1); IT (4); US (5); BE (1); FR (8); HU (2)