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NCT02394028 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,035
- Enrollment target
NCT02394028 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,035 participants.
The verdict
NCT02394028, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,035 participants
- Enrollment target
Study Summary
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
Interventions
- DRUG Placebo
- DRUG Etrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,035 participants |
| Start Date | 2015-03-20 |
| Est. Completion | 2021-09-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02394028
The ClinicalTrials.gov registry entry for NCT02394028 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,035 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 2 interventions - of which Placebo is the first listed.
NCT02394028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02394028 about?
NCT02394028 is a clinical study titled "A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease". This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants ...
What is the current status of trial NCT02394028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,035 participants. The study started on 2015-03-20. Estimated completion is 2021-09-07.
What interventions are being tested in trial NCT02394028?
The interventions under investigation include: Placebo (DRUG), Etrolizumab (DRUG).
Who is sponsoring clinical trial NCT02394028?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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