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NCT02403323 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 790
- Enrollment target
NCT02403323 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 790 participants.
The verdict
NCT02403323, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 790 participants
- Enrollment target
Study Summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Interventions
- DRUG Etrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 790 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02403323
The ClinicalTrials.gov registry entry for NCT02403323 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 790 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Etrolizumab is the first listed.
NCT02403323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02403323 about?
NCT02403323 is a clinical study titled "Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144". This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study...
What is the current status of trial NCT02403323?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 790 participants. The study started on 2015-06-08. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT02403323?
The interventions under investigation include: Etrolizumab (DRUG).
Who is sponsoring clinical trial NCT02403323?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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