Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) (DIVERGENCE 1)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Small Bowel Crohn's Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03046056

2016-003179-23 (EudraCT Number)

GS-US-419-4015

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Enrollment: 78 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit

• Moderately or severely active CD

• Minimum duration of CD of at least 6 months

• Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum

• Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present

• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

  • Corticosteroids
  • Immunomodulators
  • Tumor necrosis factor-alpha (TNFα) antagonists
  • Vedolizumab
  • Ustekinumab

• Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

Key Exclusion Criteria:

• Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
• Presence of fistulae
• Evidence of short bowel syndrome
• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
• History of total colectomy, subtotal-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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78 participants in 3 patient groups, including a placebo group

Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib

Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib

Placebo

Placebo Comparator group

Description:

PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.

Treatment:

Drug: Placebo to match filgotinib