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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 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.

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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.

Interventions

  • OTHER Placebo
  • DRUG Tulisokibart
  • DEVICE Companion Diagnostic (CDx) Testing

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2021-07-14
Est. Completion 2025-07-14
Phase Phase 2

What the Registry Record Tells You About NCT04996797

The ClinicalTrials.gov registry entry for NCT04996797 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04996797 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.