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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02914561
The ClinicalTrials.gov registry entry for NCT02914561 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lakefront Biotherapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02914561 reports 0 study locations.
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.
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