Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03077412
Other study ID # GS-US-419-4016
Secondary ID 2016-003153-15
Status Completed
Phase Phase 2
First received
Last updated
Start date April 6, 2017
Est. completion date February 17, 2021

Study information

Verified date April 2022
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date February 17, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 a (TNFa) 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily

Locations

Country Name City State
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology Vienna
Belgium Universitaire Ziekenhuizen Leuven Leuven
Canada Mount Sinai Hospital Toronto
Canada Toronto Digestive Disease Associates Inc. Toronto
France CHU Grenoble Alpes - Hopital Michallon (main office) La Tronche
France CHU de Rennes - Hôpital Pontchaillou (main office) RENNES Cedex 9
France CHU Nancy - Hopital de Brabois VandÅ“uvre-lès-Nancy
Germany Universitätsklinikum Carl Gustav Carus an der TU Dresden Dresden
Germany Universitatsklinkum Jena Jena
Hungary Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza Bekescsaba Bekes
Hungary Bugát Pál Kórház, Gasztroenterológiai osztály Gyöngyös Heves
Italy Istituto Clinico Humanitas Rozzano
United Kingdom Royal Devon and Exeter Hospital, Department of Gastroenterology Exeter
United States Texas Clinical Research Institute Arlington Texas
United States John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic Baltimore Maryland
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Gastro Center of Maryland Columbia Maryland
United States DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States University of Louisville Clinical Trials Unit Louisville Kentucky
United States University of Miami Crohn's and Colitis Center Miami Florida
United States Vanderbilt University Medical Center - IBD Clinic Nashville Tennessee
United States Center for Interventional Endoscopy - Florida Hospital Orlando Florida
United States McGuire DVAMC Richmond Virginia
United States Texas Digestive Disease Consultants Southlake Texas
United States University of South Florida South Tampa Campus Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Gilead Sciences Galapagos NV

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Achieved Combined Fistula Response at 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. Week 24
Secondary Percentage of Participants Who Achieved Combined Fistula Remission at 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. Week 24
Secondary Time to Clinical Fistula Response 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 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
Secondary Time to Clinical Fistula Remission 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. 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
Secondary Percentage of Participants Who Achieved Proctitis Remission at 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. Week 24
See also
  Status Clinical Trial Phase
Completed NCT01624376 - Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease Phase 2
Withdrawn NCT02677350 - AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE) Phase 1
Completed NCT03452501 - Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients