Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Fistulizing Crohn's Disease Clinical Trial

— Divergence2  

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Fistulizing Crohn's Disease

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	Vandœuvre-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