Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
- Conditions
- Fistulizing Crohn's Disease
- Interventions
- Registration Number
- NCT03077412
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib 200 mg Placebo to match filgotinib Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks Filgotinib 200 mg Filgotinib Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks Filgotinib 100 mg Placebo to match filgotinib Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks Placebo Placebo to match filgotinib Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks Filgotinib 100 mg Filgotinib Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Combined Fistula Response at Week 24 Week 24 Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 Week 24 Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections \> 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Percentage of Participants Who Achieved Proctitis Remission at Week 24 Week 24 The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (\>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score \> 2.
Time to Clinical Fistula Response up to Week 24 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 Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented.
Time to Clinical Fistula Remission up to Week 24 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 Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented.
Trial Locations
- Locations (27)
Gastro One
🇺🇸Germantown, Tennessee, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, 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
CHU de Rennes - Hôpital Pontchaillou (main office)
🇫🇷RENNES Cedex 9, France
Toronto Digestive Disease Associates Inc.
🇨🇦Toronto, Canada
CHU Grenoble Alpes - Hopital Michallon (main office)
🇫🇷La Tronche, France
Universitätsklinikum Carl Gustav Carus an der TU Dresden
🇩🇪Dresden, Germany
Universitatsklinkum Jena
🇩🇪Jena, Germany
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
🇭🇺Bekescsaba, Bekes, Hungary
CHU Nancy - Hopital de Brabois
🇫🇷Vandœuvre-lès-Nancy, France
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Royal Devon and Exeter Hospital, Department of Gastroenterology
🇬🇧Exeter, United Kingdom
University of Miami Crohn's and Colitis Center
🇺🇸Miami, Florida, United States
University of South Florida South Tampa Campus
🇺🇸Tampa, Florida, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, 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
Vanderbilt University Medical Center - IBD Clinic
🇺🇸Nashville, Tennessee, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Bugát Pál Kórház, Gasztroenterológiai osztály
🇭🇺Gyöngyös, Heves, Hungary
Center for Interventional Endoscopy - Florida Hospital
🇺🇸Orlando, Florida, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
University of Louisville Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States