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NCT04996797 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
A Phase 2 study, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
NCT04996797: Completed Phase 2 study, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT04996797 is a Phase 2 study that has completed, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 178 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04996797, a Phase 2 study, has completed, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Primary Outcome
The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Interventions
- OTHER Placebo
- DRUG Tulisokibart
- DEVICE Companion Diagnostic (CDx) Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2025-07-14 |
| Phase | Phase 2 |
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
What the finished NCT04996797 record still lists
NCT04996797 is an interventional study that assigns participants to a tested intervention. The registered 178 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 (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04996797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04996797 about?
NCT04996797 is a clinical study titled "A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)". The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
What is the current status of trial NCT04996797?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2021-07-14. Estimated completion is 2025-07-14.
What interventions are being tested in trial NCT04996797?
The interventions under investigation include: Placebo (OTHER), Tulisokibart (DRUG), Companion Diagnostic (CDx) Testing (DEVICE).
Who is sponsoring clinical trial NCT04996797?
This trial is sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04996797's enrollment target sits among peer trials
178 391st of 2000 higher than 1,607 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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