Phase 2
N=78
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Small Bowel Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03046056 ↗Enrolled (actual)
78
Serious AEs
14.1%
Results posted
Aug 2021
Primary outcome: Primary: Percentage of Participants Who Achieved Clinical Remission at Week 24 — 25.0; 25.0; 16.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Filgotinib (Drug); Placebo to match filgotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Remission at Week 24 |
25.0; 25.0; 16.7 | — |
| SECONDARY Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24 |
-1.8; 0.7; 0.5 | — |
| SECONDARY Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24 |
-1.1; -0.5; 0.5 | — |
| SECONDARY Change From Baseline in Jejunum Segmental MaRIA Score at Week 24 |
0.4; 0.6; 0.5 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24 |
4.5; 6.7; 6.3 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24 |
10.0; 0; 16.7 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24 |
33.3; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24 |
22.7; 10.0; 25.0 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24 |
20.0; 12.5; 16.7 | — |
| SECONDARY Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24 |
50.0; 12.5; 0 | — |
| SECONDARY Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24 |
8.0; 6.3; 0 | — |
| SECONDARY Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24 |
20.0; 12.5; 16.7 | — |
| SECONDARY Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 |
39.3; 25.0; 22.2 | — |
| SECONDARY Change From Baseline in CDAI Scores at Week 10 |
-105; -88; -57 | — |
| SECONDARY Change From Baseline in CDAI Scores at Week 24 |
-86; -71; -66 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03046056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.