Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease (Divergence2)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Fistulizing Crohn's Disease

Treatments: Drug: Filgotinib; Drug: Placebo to match filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03077412

GS-US-419-4016

2016-003153-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 3 patient groups

Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib

Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib

Placebo

Experimental group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks

Treatment:

Drug: Placebo to match filgotinib