Phase
Condition
Colic
Ulcers
Bowel Dysfunction
Treatment
Placebo
Filgotinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Universitair Ziekenhuis Leuven Campus Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Hepato-Gastroenterology HK
Hradec Králové, 500 12
CzechiaSite Not Available
GEP Clinic
Praha, 130 00
CzechiaSite Not Available
CHU Amiens-Picardie
Amiens, 80054
FranceSite Not Available
Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
Marseille, 13015
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie
Nantes, 44000
FranceSite Not Available
Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition
Pessac, 33600
FranceSite Not Available
Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie
Pierre-Bénite, 69495
FranceSite Not Available
Hôpital Pontchaillou
Rennes, 35033
FranceSite Not Available
Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
Saint-Étienne, 42055
FranceSite Not Available
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie
Vandœuvre-lès-Nancy, 54500
FranceSite Not Available
DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend
Berlin, 14050
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
GermanySite Not Available
EUGASTRO GmbH
Leipzig, 04103
GermanySite Not Available
Klinikum Lüneburg
Lüneburg, 21339
GermanySite Not Available
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423
GermanySite Not Available
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, 1097
HungarySite Not Available
Bugát Pál Kórház
Gyöngyös, 3200
HungarySite Not Available
IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II
Castellana Grotte, 70013
ItalySite Not Available
Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva
Catanzaro, 88100
ItalySite Not Available
Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello
Pisa, 56124
ItalySite Not Available
Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Yeungnam University Medical Center
Daegu, 42415
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul, 02447
Korea, Republic ofSite Not Available
Yonsei University Health System Severance Hospital Gastroenterology
Seoul, 03722
Korea, Republic ofSite Not Available
Przychodnia Vitamed NFZ
Bydgoszcz, 85-079
PolandSite Not Available
Gabinet Endoskopii Przewodu Pokarmowego
Kraków, 31-009
PolandSite Not Available
Krakowskie Centrum Medyczne
Kraków, 31-501
PolandSite Not Available
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, 95-054
PolandSite Not Available
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, 35-302
PolandSite Not Available
Endoskopia Sopot
Sopot, 81-756
PolandSite Not Available
Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
Toruń, 87-100
PolandSite Not Available
H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością
Tychy, 43-100
PolandSite Not Available
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warsaw, 03-580
PolandSite Not Available
Bodyclinic
Warszawa, 03-712
PolandSite Not Available
Centrum Medyczne Oporów
Wrocław, 52-416
PolandSite Not Available
Santa Familia - Centrum Badań Profilaktyki i Leczenia
Łódź, 90-302
PolandSite Not Available
Mediclinic Panorama
Cape Town, 7500
South AfricaSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainSite Not Available
National Taiwan University Hospital Center for Infection Control
Taipei, 10002
TaiwanSite Not Available
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
Norfolk and Norwich University Hospital
Norwich, NR4 YUY
United KingdomSite Not Available
Saint Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR
United KingdomSite Not Available
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Gastroenterology Group of Naples
Naples, Florida 34102
United StatesSite Not Available
Gastro Center of Maryland - Columbia
Columbia, Maryland 21045
United StatesSite Not Available
Rapid City Medical Center
Rapid City, South Dakota 57701
United StatesSite Not Available
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320
United StatesSite Not Available
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