Phase 2
Completed N=78
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Source: ClinicalTrials.gov NCT03046056 ↗Enrolled (actual)
78
Serious AEs
14.1%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Remission at Week 24 — 25.0; 25.0; 16.7 percentage of participants
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.
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 | — |
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. Informational only — not medical advice.