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NCT02914522 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,351
- Enrollment target
NCT02914522: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02914522 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 1,351 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02914522, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,351 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
Primary Outcome
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at
Interventions
- DRUG Filgotinib
- DRUG PTM filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,351 participants |
| Start Date | 2016-11-14 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 3 |
What the finished NCT02914522 record still lists
NCT02914522 is an interventional study that assigns participants to a tested intervention. Its 1,351 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 2 interventions - of which Filgotinib is the first listed.
NCT02914522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02914522 about?
NCT02914522 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis". The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol s...
What is the current status of trial NCT02914522?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,351 participants. The study started on 2016-11-14. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT02914522?
The interventions under investigation include: Filgotinib (DRUG), PTM filgotinib (DRUG).
Who is sponsoring clinical trial NCT02914522?
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 NCT02914522's enrollment target sits among peer trials
1,351 181st of 2000 higher than 1,820 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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