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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03077412
• Date of registration: 08/03/2017
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease Divergence2
• Scientific 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
• Date of first enrolment: April 6, 2017
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03077412
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fistulizing Crohn's Disease

Intervention(s)

Drug: Filgotinib

Drug: Placebo to match filgotinib

Primary Outcome(s)

Percentage of Participants Who Achieved Combined Fistula Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Time to Clinical Fistula Response up to Week 24 [Time Frame: 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]

Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 [Time Frame: Week 24]

Percentage of Participants Who Achieved Proctitis Remission at Week 24 [Time Frame: Week 24]

Time to Clinical Fistula Remission up to Week 24 [Time Frame: 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 ID(s)

2016-003153-15

GS-US-419-4016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Galapagos NV

Results

• Results available: Yes
• Date Posted: 08/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03077412