Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Launched by GILEAD SCIENCES · Sep 22, 2016
Trial Information
Current as of May 20, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
- • Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
- • A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
- • Moderately to severely active UC
- • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
- Key Exclusion Criteria:
- • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- • Active tuberculosis (TB) or history of latent TB that has not been treated
- • Use of any concomitant prohibited medications as described in the protocol
- • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Rochester, Minnesota, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
Caen, , France
Oviedo, , Spain
Hong Kong, , Hong Kong
Utrecht, , Netherlands
Dublin, , Ireland
Saskatoon, Saskatchewan, Canada
Scottsdale, Arizona, United States
Barcelona, , Spain
Houston, Texas, United States
Christchurch, , New Zealand
Charlottesville, Virginia, United States
Cincinnati, Ohio, United States
Richmond, Virginia, United States
Haifa, , Israel
Tampa, Florida, United States
Woodville South, South Australia, Australia
Singapore, , Singapore
Rozzano, , Italy
Los Angeles, California, United States
Madrid, , Spain
Winter Park, Florida, United States
Woolloongabba, Queensland, Australia
Malvern, Victoria, Australia
Taipei, , Taiwan
Melbourne, Victoria, Australia
Footscray, Victoria, Australia
Chesapeake, Virginia, United States
Chesterfield, Michigan, United States
Clayton, Victoria, Australia
Heidelberg, Victoria, Australia
Long Beach, California, United States
Freiburg, , Germany
Kingswood, New South Wales, Australia
Seoul, , Korea, Republic Of
Darlinghurst, New South Wales, Australia
Mumbai, , India
Sevilla, , Spain
Hong Kong, , Hong Kong
Jerusalem, , Israel
Troy, Michigan, United States
Paris, , France
Port Orange, Florida, United States
Jerusalem, , Israel
Leuven, , Belgium
Nashville, Tennessee, United States
Seoul, , Korea, Republic Of
New Delhi, , India
Zagreb, , Croatia
Hamilton, , New Zealand
Uppsala, , Sweden
Chennai, , India
Petach Tikva, , Israel
Berlin, , Germany
Macon, Georgia, United States
Naples, Florida, United States
Monroe, Louisiana, United States
Berlin, , Germany
Hagerstown, Maryland, United States
Sopot, , Poland
Derby, , United Kingdom
Jerusalem, , Israel
Zürich, , Switzerland
Kiel, , Germany
Marietta, Georgia, United States
Hamburg, , Germany
Oxford, , United Kingdom
Dothan, Alabama, United States
Germantown, Tennessee, United States
Annapolis, Maryland, United States
Jena, , Germany
Kofu Shi, , Japan
Toulouse, , France
Innsbruck, , Austria
Frankfurt Am Main, , Germany
Minden, , Germany
San Antonio, Texas, United States
Southlake, Texas, United States
Miami, Florida, United States
Suita, , Japan
Great Neck, New York, United States
Columbia, Maryland, United States
Edinburgh, , United Kingdom
Saga, , Japan
Marseille, , France
Madrid, , Spain
Shreveport, Louisiana, United States
Chevy Chase, Maryland, United States
Nashville, Tennessee, United States
Mentor, Ohio, United States
Houston, Texas, United States
Hradec Kralove, , Czechia
Haifa, , Israel
Lone Tree, Colorado, United States
Seoul, , Korea, Republic Of
Zagreb, , Croatia
Morioka Shi, , Japan
Daegu, , Korea, Republic Of
Kansas City, Missouri, United States
Porto, , Portugal
Orangeburg, South Carolina, United States
Brooklyn, New York, United States
Chattanooga, Tennessee, United States
Szczecin, , Poland
Brussels, , Belgium
Gainesville, Florida, United States
Herne, , Germany
George Town, , Malaysia
Kurume Shi, , Japan
Amiens, , France
Grafton, , New Zealand
Suwon Si, Gyeonggi Do, Korea, Republic Of
Madison, Wisconsin, United States
Seoul, , Korea, Republic Of
Rapid City, South Dakota, United States
Leipzig, , Germany
Miami, Florida, United States
Garland, Texas, United States
Lakewood Ranch, Florida, United States
La Tronche, , France
Scottsdale, Arizona, United States
Farmington, Connecticut, United States
Zephyrhills, Florida, United States
Suwanee, Georgia, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Raleigh, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Fort Sam Houston, Texas, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
The Woodlands, Texas, United States
Bountiful, Utah, United States
Lansdowne Town Center, Virginia, United States
Wauwatosa, Wisconsin, United States
Mar Del Plata, , Argentina
Quilmes, , Argentina
Mountain Creek, Queensland, Australia
South Brisbane, Queensland, Australia
Wien, , Austria
Antwerpen, , Belgium
Liège, , Belgium
Pleven, , Bulgaria
Veliko Tŭrnovo, , Bulgaria
Vidin, , Bulgaria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Vaughan, , Canada
Mladá Boleslav, , Czechia
Praha 3, , Czechia
Praha 9, , Czechia
Clermont Ferrand, , France
Clichy, , France
Dijon, , France
Le Kremlin Bicêtre, , France
Lille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Pessac, , France
Pierre Benite, , France
Rennes Cedex 9, , France
Saint Priest En Jarez, , France
Vandœuvre Lès Nancy, , France
Batumi, , Georgia
Tbilisi, , Georgia
Telavi, , Georgia
Berlin, , Germany
Braunschweig, , Germany
Hannöver, , Germany
Koln, , Germany
Lüneburg, , Germany
Muenchen, , Germany
Tuebingen, , Germany
Ulm, , Germany
Athens, , Greece
Athens, , Greece
Sha Tin, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Békéscsaba, , Hungary
Debrecen, , Hungary
Gyöngyös, , Hungary
Mosonmagyaróvár, , Hungary
Ahmedabad, , India
Bangalore, , India
Coimbatore, , India
Hyderabad, , India
Hyderabad, , India
Hyderabad, , India
Jaipur, , India
Jaipur, , India
Kolkata, , India
Ludhiana, , India
Mangaluru, , India
Nagpur, , India
Nagpur, , India
Pune, , India
Rajkot, , India
Secunderabad, , India
Secunderabad, , India
Surat, , India
Udupi, , India
Vadodara, , India
Varanasi, , India
Beer Sheva, , Israel
Castellana Grotte, , Italy
Catanzaro, , Italy
Chieti, , Italy
Milano, , Italy
Padova, , Italy
Pisa, , Italy
Roma, , Italy
Bunkyo Ku, , Japan
Chikushino Shi, , Japan
Chuo Ku, , Japan
Fukuoka Shi, , Japan
Hachioji Shi, , Japan
Hiroshima Shi, , Japan
Jonan Ku, , Japan
Kamakura, , Japan
Kitakyushu Shi, , Japan
Kurume Shi, , Japan
Kyoto Shi, , Japan
Minato Ku, , Japan
Minato Ku, , Japan
Mitaka Shi, , Japan
Nagakute Shi, , Japan
Nagasaki Shi, , Japan
Nishi Ku, , Japan
Nishinomiya, , Japan
Oita Shi, , Japan
Okayama City, , Japan
Osaka, , Japan
Saga Shi, , Japan
Sagamihara, , Japan
Saitama, , Japan
Sakura, , Japan
Sapporo Shi, , Japan
Sapporo, , Japan
Sendai, , Japan
Shinjuku Ku, , Japan
Takamatsu Shi, , Japan
Takasaki Shi, , Japan
Takatsuki, , Japan
Toyota Shi, , Japan
Wakayama Shi, , Japan
Yokohama Shi, , Japan
Yokohama Shi, , Japan
ōsaka, , Japan
ōsaka, , Japan
ōtsu, , Japan
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Wŏnju, , Korea, Republic Of
Cheras, , Malaysia
Kota Kinabalu, , Malaysia
Cuautitlán Izcalli, , Mexico
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Newtown, , New Zealand
Tauranga, , New Zealand
Drammen, , Norway
Lørenskog, , Norway
Białystok, , Poland
Bydgoszcz, , Poland
Bydgoszcz, , Poland
Częstochowa, , Poland
Katowice, , Poland
Kraków, , Poland
Kraków, , Poland
Ksawerów, , Poland
Piaseczno, , Poland
Poznan, , Poland
Rzeszów, , Poland
Toruń, , Poland
Tychy, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
łódź, , Poland
Guimarães, , Portugal
Bucuresti, , Romania
Bucuresti, , Romania
Oradea, , Romania
Timişoara, , Romania
Chelyabinsk, , Russian Federation
Irkutsk, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhniy Novgorod, , Russian Federation
Novosibirsk, , Russian Federation
Novosibirsk, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saratov, , Russian Federation
Smolensk, , Russian Federation
Tyumen, , Russian Federation
Belgrade, , Serbia
Nitra, , Slovakia
Cape Town, , South Africa
Johannesburg, , South Africa
Danderyd, , Sweden
Malmo, , Sweden
Bern, , Switzerland
Chang Hua, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Cherkasy, , Ukraine
Chernivtsi, , Ukraine
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Ivano Frankivs'k, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kropyvnytskyi, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Odessa, , Ukraine
Odessa, , Ukraine
Ternopil, , Ukraine
Vinnytsia, , Ukraine
Vinnytsya, , Ukraine
Vinnytsya, , Ukraine
Zaporizhzhya, , Ukraine
Bury, , United Kingdom
Cambridge, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
High Wycombe, , United Kingdom
London, , United Kingdom
Norwich, , United Kingdom
Nottingham, , United Kingdom
Prescot, , United Kingdom
Southampton, , United Kingdom
Patients applied
Trial Officials
Gilead Study Director
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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