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NCT03077412 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT03077412: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT03077412 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03077412, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Interventions
- DRUG Filgotinib
- DRUG Placebo to match filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-04-06 |
| Est. Completion | 2021-02-17 |
| Phase | Phase 2 |
What the finished NCT03077412 record still lists
NCT03077412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Filgotinib is the first listed.
NCT03077412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03077412 about?
NCT03077412 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease". 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 requ...
What is the current status of trial NCT03077412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2017-04-06. Estimated completion is 2021-02-17.
What interventions are being tested in trial NCT03077412?
The interventions under investigation include: Filgotinib (DRUG), Placebo to match filgotinib (DRUG).
Who is sponsoring clinical trial NCT03077412?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03077412's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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