Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Alfasigma S.p.A.
Study ID
NCT02914535
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Filgotinib — DRUG
    Tablet(s) administered orally once daily
  • Placebo — DRUG
    Tablet(s) administered orally once daily

Study Details

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).

Key Dates

First listed
Sep 26, 2016
Start date
Feb 23, 2017
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,173 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Filgotinib 200 mg (blinded dosing)
    Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
  • Experimental: Filgotinib 100 mg (blinded dosing)
    Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
  • Placebo Comparator: Placebo (blinded dosing)
    Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
  • Experimental: Filgotinib 200 mg (open-label)
    Filgotinib 200 mg for up to 336 weeks
  • Experimental: Filgotinib 100 mg (open-label)
    Filgotinib 100 mg for up to 336 weeks

Primary Outcome Measure

Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [ Time Frame: Up to 336 weeks plus 30 days ]

Locations (57)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists Of The SoutheastDothanAlabama36305-
Mayo Clinic ArizonaScottsdaleArizona85259-
VA Long Beach Healthcare SystemLong BeachCalifornia90822-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
South Denver Gastroenterology, PCLone TreeColorado80124-
Connecticut GI PC-Research DivisionFarmingtonConnecticut06032-
UF Clinical Research CenterGainesvilleFlorida32610-
Florida Research InstituteLakewood RchFlorida34211-
Cordova Research InstituteMiamiFlorida33155-
University of Miami Crohn's and Colitis CenterMiamiFlorida33136-
Gastroenterology Group of NaplesNaplesFlorida34102-
Advanced Medical Research CenterPort OrangeFlorida32127-
Tampa General HospitalTampaFlorida33606-
Florida Medical Clinic, P.AZephyrhillsFlorida33540-
Gastroenterology Associates Of Central Georgia, LLCMaconGeorgia31201-
Gastrointestinal Specialists of GeorgiaMariettaGeorgia30060-
Atlanta Gastroenterology Specialist, PCSuwaneeGeorgia30024-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Louisville, Clinical Trials UnitLouisvilleKentucky40202-
Delta Research Partners, LLCMonroeLouisiana71201-
Louisiana Research Center, LLCShreveportLouisiana71105-
Investigative Clinical ResearchAnnapolisMaryland21401-
MGG Group Co., Inc., Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Gastro Center of MarylandColumbiaMaryland21045-
Meritus Center for Clinical ResearchHagerstownMaryland21742-
Massachusetts General Hospital - Crohn's and Colitis CenterBostonMassachusetts02114-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Center for Digestive Health ResearchTroyMichigan48098-
Mayo ClinicRochesterMinnesota55905-
Kansas City Research InstituteKansas CityMissouri64131-
Washington University School of MedicineSt LouisMissouri63110-
NY ScientificBrooklynNew York11235-
NYU Langone Long Island Clinical Research AssociatesGreat NeckNew York11021-
Carolina's GI Research LLCRaleighNorth Carolina27607-
Fargo Gastroenterology and Hepatology ClinicFargoNorth Dakota58103-
Consultants for Clinical ResearchCincinnatiOhio45219-
UC Health Physicians CliftonCincinnatiOhio45219-
Great Lakes Gastroenterology Research, LLCMentorOhio44060-
Gastroenterology Associates of OrangeburgOrangeburgSouth Carolina29118-
Rapid City Medical CenterRapid CitySouth Dakota57701-
Gastro OneGermantownTennessee38138-
Quality Medical ResearchNashvilleTennessee37211-
Vanderbilt University Medical Center - IBD ClinicNashvilleTennessee37212-1375-
San Antonio Military Medical CenterFort Sam HoustonTexas78219-
DHAT Research InstituteGarlandTexas75044-
Baylor College of Medicine - Baylor Medical CenterHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
Clinical Associates in Research Therapeutics of America, LLCSan AntonioTexas78212-
Gastroenterology Research of San AntonioSan AntonioTexas78229-
TDDC San MarcosSan MarcosTexas78666-
Texas Digestive Disease ConsultantsSouthlakeTexas76092-
Spring GastroenterologyThe WoodlandsTexas77380-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Gastroenterology Associates of TidewaterChesapeakeVirginia23320-
McGuire DVAMCRichmondVirginia23249-
University of Wisconsin Hospital & ClinicsMadisonWisconsin53705-
Allegiance Research Specialists, LLCWauwatosaWisconsin53225-

Find similar trials in Dothan, AL

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By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists Of The Southeast· Dothan, ALMayo Clinic Arizona· Scottsdale, AZVA Long Beach Healthcare System· Long Beach, CACedars Sinai Medical Center· Los Angeles, CASouth Denver Gastroenterology, PC· Lone Tree, COConnecticut GI PC-Research Division· Farmington, CT

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