Clinical trial NCT05479058: A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
timeFrame: Week 48
Secondary outcomes:
measure: Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
timeFrame: Baseline up to Week 48
measure: Time to ES-Confirmed UC Flare
timeFrame: Baseline up to Week 48
measure: Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
measure: Change From Baseline in Fecal Calprotectin (FCP)
timeFrame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Baseline, Week 48
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Columbia
country: United States
facility: Gastro Center of Maryland - Columbia
state: Maryland
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven Campus Gasthuisberg
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterology HK
city: Praha
country: Czechia
facility: GEP Clinic
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Marseille
country: France
facility: Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie
city: Pessac
country: France
facility: Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint-Étienne
country: France
facility: Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie
city: Berlin
country: Germany
facility: DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház
city: Castellana Grotte
country: Italy
facility: IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello
city: Rozzano
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital Gastroenterology
city: Bydgoszcz
country: Poland
facility: Przychodnia Vitamed NFZ
city: Kraków
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Ksawerów
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
city: Sopot
country: Poland
facility: Endoskopia Sopot
city: Toruń
country: Poland
facility: Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością
city: Warsaw
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz
city: Warszawa
country: Poland
facility: Bodyclinic
city: Wrocław
country: Poland
facility: Centrum Medyczne Oporów
city: Łódź
country: Poland
facility: Santa Familia - Centrum Badań Profilaktyki i Leczenia
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Center for Infection Control
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Prescot
country: United Kingdom
facility: Saint Helens and Knowsley Teaching Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References: