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NCT02954159 · ClinicalTrials.gov registry record · Phase 3
Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC
A Phase 3 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT02954159: Clinical Trial Phase 3 study, sponsored by Medical College of Wisconsin.
NCT02954159 is a Phase 3 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02954159, a Phase 3 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and its effect on long and short-term outcomes including colectomy rate. Secondary aim of this study is to assess the safety of tacrolimus as an induction agent in patients with UC.
Primary Outcome
Steroid-free clinical response at week 6 after starting vedolizumab, defined as a reduction in the Mayo Clinic score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1 while off steroids.
Interventions
- OTHER Placebo
- DRUG Vedolizumab
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2017-05-18 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 3 |
Why NCT02954159 stopped before completion
NCT02954159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02954159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02954159 about?
NCT02954159 is a clinical study titled "Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC". The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and its effect on long and short-term outcomes including colectomy rate. Secondary aim of this study is to assess the ...
What is the current status of trial NCT02954159?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2017-05-18. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT02954159?
The interventions under investigation include: Placebo (OTHER), Vedolizumab (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT02954159?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02954159's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 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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