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NCT03558152 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT03558152: Completed Phase 2 study, sponsored by Genentech.
NCT03558152 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 195 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03558152, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
Primary Outcome
Clinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Interventions
- DRUG Vedolizumab
- DRUG UTTR1147A
- DRUG UTTR1147A Placebo
- DRUG Vedolizumab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2018-10-26 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 2 |
What the finished NCT03558152 record still lists
NCT03558152 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 4 interventions - of which Vedolizumab is the first listed.
NCT03558152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03558152 about?
NCT03558152 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)". This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remis...
What is the current status of trial NCT03558152?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2018-10-26. Estimated completion is 2021-12-15.
What interventions are being tested in trial NCT03558152?
The interventions under investigation include: Vedolizumab (DRUG), UTTR1147A (DRUG), UTTR1147A Placebo (DRUG), Vedolizumab Placebo (DRUG).
Who is sponsoring clinical trial NCT03558152?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03558152's enrollment target sits among peer trials
195 350th of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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