Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
NCT ID: NCT03077412
Last Updated: 2022-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2017-04-06
2021-02-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
NCT03046056
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
NCT02914561
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
NCT02914522
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
NCT02914600
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
NCT05479058
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Placebo to match filgotinib
Tablet(s) administered orally once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
* Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
* Antibiotics AND/OR
* Immunomodulators AND/OR
* Tumor necrosis factor α (TNFα) Antagonist
* Is willing and able to undergo MRI per protocol requirements
* Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
Exclusion Criteria
* Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
* Use of any prohibited concomitant medications as described in the study protocol
* Active tuberculosis (TB) or history of latent TB that has not been treated
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States
University of South Florida South Tampa Campus
Tampa, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Louisville Clinical Trials Unit
Louisville, Kentucky, United States
John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic
Baltimore, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
DHAT Research Institute
Garland, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
Klinikum Klagenfurt am Wörthersee
Klagenfurt, , Austria
Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, , Austria
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Mount Sinai Hospital
Toronto, , Canada
Toronto Digestive Disease Associates Inc.
Toronto, , Canada
CHU Grenoble Alpes - Hopital Michallon (main office)
La Tronche, , France
CHU de Rennes - Hôpital Pontchaillou (main office)
Rennes, , France
CHU Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Universitatsklinkum Jena
Jena, , Germany
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
Békéscsaba, Bekes County, Hungary
Bugát Pál Kórház, Gasztroenterológiai osztály
Gyöngyös, Heves County, Hungary
Istituto Clinico Humanitas
Rozzano, , Italy
Royal Devon and Exeter Hospital, Department of Gastroenterology
Exeter, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Reinisch W, Colombel JF, D'Haens GR, Rimola J, Masior T, McKevitt M, Ren X, Serone A, Schwartz DA, Gecse KB. Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulising Crohn's Disease [DIVERGENCE 2]: A Phase 2, Randomised, Placebo-controlled Trial. J Crohns Colitis. 2024 Jun 3;18(6):864-874. doi: 10.1093/ecco-jcc/jjae003.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-003153-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-419-4016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.