Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Phase 3 – large-scale trial before approval
Conditions:
Ulcerative Colitis
Sponsor: Alfasigma S.p.A.
trial.available_in:
БГ
Overview
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Who can participate
Key Inclusion Criteria:
* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
* Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
* Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
* Females of childbearing potential must have a negative pregnancy test at Day 1
* Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Key Exclusion Criteria:
* Known hypersensitivity to the study drug
* 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 subject unsuitable for the study or would prevent compliance with the study protocol
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
* Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Locations
36
Argentina (1)
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata
Australia (1)
Monash Medical Centre
Clayton , New South Wales
Belgium (1)
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp
Bulgaria (1)
MHAT Sveti Pantaleymon- Pleven OOD
Pleven
Canada (1)
University of Calgary, Heritage Medical Research Clinic
Calgary , Alberta
Croatia (1)
Clinical Hospital Dubrava
Zagreb
Czech Republic (1)
Hepato-Gastroenterology HK, s.r.o.
Hradec Králové
France (1)
CHU Amiens Picardie
Amiens
Georgia (1)
Unimed Ajara LLC - Batumi Referral Hospital
Batumi
Germany (1)
Universitatsklinikum Schleswig-Holstein
Kiel , Schleswig-Holstein
Greece (1)
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens
Hong Kong (1)
Princess Margaret Hospital
Hong Kong
Hungary (1)
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba
India (1)
Kaizen Hospital
Ahmedabad
Ireland (1)
Beaumont Hospital
Dublin
Israel (1)
Bnai Zion Medical Center
Haifa
Italy (1)
UOC Gastroenterologia II
Castellana Grotte
Japan (1)
Nagasaki University Hospital
Nagasaki , Nagasaki
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli
Netherlands (1)
Academic Medical Center (AMC)
Amsterdam
New Zealand (1)
Christchurch Hospital
Christchurch
Poland (1)
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok
Romania (1)
MedLife, Gastroenterologie
Bucharest
Russia (1)
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk
Serbia (1)
Zvezdara University Medical Center
Belgrade
Singapore (1)
Singapore General Hospital
Singapore
Slovakia (1)
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
South Africa (1)
Dr MJ Prins
Cape Town
South Korea (1)
The Catholic University of Korea, St. Vincent's Hospital
Suwon , Gyeonggi-do
Spain (1)
Centro Medico Teknon
Barcelona
Sweden (1)
Skane University Hospital
Malmo
Taiwan (1)
Changhua Christian Hospital
Changhua
Ukraine (1)
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy
United Kingdom (1)
Norfolk and Norwich University Hospital NHS Foundation Trust