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NCT02163759 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
NCT02163759: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02163759 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 358 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02163759, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
Study Summary
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.
Primary Outcome
The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Participants were
Interventions
- DRUG Adalimumab
- OTHER Adalimumab Placebo
- DRUG Etrolizumab
- OTHER Etrolizumab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2014-11-04 |
| Est. Completion | 2020-03-19 |
| Phase | Phase 3 |
What the finished NCT02163759 record still lists
NCT02163759 is an interventional study that assigns participants to a tested intervention. The registered 358 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 (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Adalimumab is the first listed.
NCT02163759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02163759 about?
NCT02163759 is a clinical study titled "A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors". This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibito...
What is the current status of trial NCT02163759?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2014-11-04. Estimated completion is 2020-03-19.
What interventions are being tested in trial NCT02163759?
The interventions under investigation include: Adalimumab (DRUG), Adalimumab Placebo (OTHER), Etrolizumab (DRUG), Etrolizumab Placebo (OTHER).
Who is sponsoring clinical trial NCT02163759?
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 NCT02163759's enrollment target sits among peer trials
358 1022nd of 2000 higher than 978 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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