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Completed

NCT Number: NCT03077412

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

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.

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Key information

Conditions

Fistulizing Crohn's Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgotinib

Drug

Tablet(s) administered orally once daily

Other names: GS-6034, GLPG0634

Placebo to match filgotinib

Drug

Tablet(s) administered orally once daily

Primary outcomes

  1. Percentage of Participants Who Achieved Combined Fistula Response at Week 24

    Time frame: 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 outcomes

  1. Percentage of Participants Who Achieved Combined Fistula Remission at Week 24

    Time frame: 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.

  2. 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

    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.

  3. 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

    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.

  4. Percentage of Participants Who Achieved Proctitis Remission at Week 24

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Lakefront Biotherapeutics NV

Registry information

Official study 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

Acronym: Divergence2

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2017
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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