Clinical trial NCT03077412: Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fistulizing Crohn's Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2017-03-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.


Eligibility criteria: Key Inclusion Criteria:

* Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
* 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

Key Exclusion Criteria:

* Presence of current rectovaginal anovaginal or enterovesicular fistulae
* 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieved Combined Fistula Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved Combined Fistula Remission at Week 24
timeFrame: Week 24
measure: Time to Clinical Fistula Response up to Week 24
timeFrame: Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24
measure: Time to Clinical Fistula Remission up to Week 24
timeFrame: Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24
measure: Percentage of Participants Who Achieved Proctitis Remission at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Orlando
country: United States
facility: Center for Interventional Endoscopy - Florida Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida South Tampa Campus
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Clinical Trials Unit
state: Kentucky
city: Baltimore
country: United States
facility: John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - IBD Clinic
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Toronto
country: Canada
facility: Toronto Digestive Disease Associates Inc.
city: La Tronche
country: France
facility: CHU Grenoble Alpes - Hopital Michallon (main office)
city: RENNES Cedex 9
country: France
facility: CHU de Rennes - Hôpital Pontchaillou (main office)
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy - Hopital de Brabois
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Jena
country: Germany
facility: Universitatsklinkum Jena
city: Bekescsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
state: Bekes
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház, Gasztroenterológiai osztály
state: Heves
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, Department of Gastroenterology
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: