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ACTIVE NOT RECRUITING Phase 3

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

NCT06052059 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.

Conditions Studied

Interventions

  • DRUG IV Placebo
  • DRUG IV Tulisokibart
  • DRUG SC Tulisokibart
  • DRUG SC Placebo

Study Locations (20)

California

  • Clinnova Research ( Site 3803) — Anaheim
  • Southern California Research Center ( Site 3828) — Coronado
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) — La Jolla
  • Cedars-Sinai Medical Center ( Site 0119) — Los Angeles
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) — Orange

Colorado

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) — Aurora
  • Peak Gastroenterology Associates ( Site 0116) — Colorado Springs
  • South Denver Gastroenterology, PC ( Site 3849) — Englewood
  • Rocky Mountain Gastroenterology/Topography Health ( Site 3838) — Littleton

Arizona

  • Research Solutions of Arizona ( Site 3816) — Litchfield Park
  • One of a Kind Clinical Research Center ( Site 3852) — Scottsdale
  • GI Alliance - Sun City ( Site 0103) — Sun City

Connecticut

  • Connecticut Clinical Research Institute ( Site 0126) — Bristol
  • Medical Research Center of Connecticut ( Site 0151) — Hamden
  • Yale University School of Medicine-Digestive Disease ( Site 0163) — New Haven

Alabama

  • Digestive Health Specialists ( Site 0135) — Dothan
  • IMC-Gulf Coast Gastroenterology ( Site 0157) — Fairhope

Florida

  • Gastroenterology Consultants of Clearwater ( Site 0152) — Clearwater
  • University of Florida College of Medicine-Gastroenterology ( Site 3821) — Gainesville

District of Columbia

  • Emerson Clinical Research Institute ( Site 3820) — Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,020 participants
Start Date 2023-10-25
Est. Completion 2029-08-01
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06052059

The ClinicalTrials.gov registry entry for NCT06052059 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 4 interventions — of which IV Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06052059 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06052059 about?

NCT06052059 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)". The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remissi...

What is the current status of trial NCT06052059?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,020 participants. The study started on 2023-10-25. Estimated completion is 2029-08-01.

What conditions does trial NCT06052059 study?

This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06052059?

The interventions under investigation include: IV Placebo (DRUG), IV Tulisokibart (DRUG), SC Tulisokibart (DRUG), SC Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06052059?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06052059 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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