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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02394028 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,035 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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 |
What the finished NCT02394028 record still lists
NCT02394028 is an interventional study that assigns participants to a tested intervention. Its 1,035 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 (34% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02394028 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02394028's enrollment target sits among peer trials
1,035 287th of 2000 higher than 1,713 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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