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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 358 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02163759
The ClinicalTrials.gov registry entry for NCT02163759 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 358 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 4 interventions - of which Adalimumab is the first listed.
NCT02163759 reports 0 study locations.
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.
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