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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT03046056
• Date of registration: 06/02/2017
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) DIVERGENCE 1
• Scientific title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
• Date of first enrolment: April 11, 2017
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03046056
• 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, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & 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 (TNFa) 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.



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

Health Condition(s) or Problem(s) studied

Small Bowel Crohn's Disease

Intervention(s)

Drug: Placebo to match filgotinib

Drug: Filgotinib

Primary Outcome(s)

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

Secondary Outcome(s)

Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24 [Time Frame: Week 24]

Change From Baseline in CDAI Scores at Week 10 [Time Frame: Baseline; Week 10]

Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24 [Time Frame: Week 24]

Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24 [Time Frame: Baseline; Week 24]

Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [Time Frame: Week 10]

Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24 [Time Frame: Week 24]

Change From Baseline in CDAI Scores at Week 24 [Time Frame: Baseline; Week 24]

Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24 [Time Frame: Week 24]

Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24 [Time Frame: Baseline; Week 24]

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24 [Time Frame: Week 24]

Change From Baseline in Jejunum Segmental MaRIA Score at Week 24 [Time Frame: Baseline; Week 24]

Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24 [Time Frame: Week 24]

Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24 [Time Frame: Week 24]

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24 [Time Frame: Week 24]

Secondary ID(s)

2016-003179-23

GS-US-419-4015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Galapagos NV

Results

• Results available: Yes
• Date Posted: 09/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03046056