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NCT02914561 · ClinicalTrials.gov registry record · Phase 3
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Lakefront Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,372
- Enrollment target
NCT02914561: Completed Phase 3 study, sponsored by Lakefront Biotherapeutics.
NCT02914561 is a Phase 3 study that has completed, run by Lakefront Biotherapeutics. The registered enrollment target is 1,372 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02914561, a Phase 3 study, has completed, sponsored by Lakefront Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,372 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
Primary Outcome
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Add
Interventions
- OTHER Placebo
- DRUG Filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,372 participants |
| Start Date | 2016-10-31 |
| Est. Completion | 2022-11-11 |
| Phase | Phase 3 |
What the finished NCT02914561 record still lists
NCT02914561 is an interventional study that assigns participants to a tested intervention. Its 1,372 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 (78% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02914561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02914561 about?
NCT02914561 is a clinical study titled "Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease". The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not...
What is the current status of trial NCT02914561?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,372 participants. The study started on 2016-10-31. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT02914561?
The interventions under investigation include: Placebo (OTHER), Filgotinib (DRUG).
Who is sponsoring clinical trial NCT02914561?
This trial is sponsored by Lakefront Biotherapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02914561's enrollment target sits among peer trials
1,372 177th of 2000 higher than 1,824 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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