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NCT02100696 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 609
- Enrollment target
NCT02100696: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02100696 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 609 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02100696, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 609 participants
- Enrollment target
Study Summary
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.
Primary Outcome
The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Interventions
- DRUG Placebo
- DRUG Etrozulimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 609 participants |
| Start Date | 2014-05-21 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 3 |
What the finished NCT02100696 record still lists
NCT02100696 is an interventional study that assigns participants to a tested intervention. The registered 609 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02100696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02100696 about?
NCT02100696 is a clinical study titled "A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors". This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been pr...
What is the current status of trial NCT02100696?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2014-05-21. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT02100696?
The interventions under investigation include: Placebo (DRUG), Etrozulimab (DRUG).
Who is sponsoring clinical trial NCT02100696?
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 NCT02100696's enrollment target sits among peer trials
609 602nd of 2000 higher than 1,398 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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