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NCT06430801 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

A Phase 3 study of Crohn's Disease, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,200
Enrollment target
20
Study locations

NCT06430801: Recruiting Phase 3 study of Crohn's Disease, sponsored by Merck Sharp & Dohme.

NCT06430801 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, below the 2,383-participant average among 105 other Crohn's Disease trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06430801, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,200 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Primary Outcome

The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

Conditions Studied

Crohn's Disease

Interventions

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

Study Locations (20)

California

  • Clinnova Research ( Site 5110) - Anaheim
  • Southern California Research Center ( Site 5044) - Coronado
  • Om Research LLC ( Site 5038) - Lancaster
  • Cedars Sinai Medical Center ( Site 5080) - Los Angeles
  • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116) - Los Angeles
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128) - Orange
  • Om Research LLC ( Site 5045) - Oxnard
  • Clinical Applications Laboratories ( Site 5123) - San Diego
  • Amicis Research Center ( Site 5055) - Valencia

Colorado

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026) - Aurora
  • Peak Gastroenterology Associates ( Site 5023) - Colorado Springs
  • South Denver Gastroenterology, PC ( Site 5132) - Englewood
  • Rocky Mountain Gastroenterology ( Site 5082) - Lakewood

Arizona

  • Arizona Arthritis & Rheumatology Research, PC ( Site 5094) - Phoenix
  • GI Alliance - Sun City ( Site 5118) - Sun City
  • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111) - Tucson

Connecticut

  • Medical Research Center of Connecticut ( Site 5005) - Hamden
  • Yale University School of Medicine-Digestive Disease ( Site 5019) - New Haven

Alabama

  • Digestive Health Specialists ( Site 5064) - Dothan

Arkansas

  • University of Arkansas for Medical Sciences ( Site 5147) - Little Rock

Trial Details

FieldValue
Enrollment Target 1,200 participants
Start Date 2024-06-05
Est. Completion 2029-11-12
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06430801 shows while recruiting

NCT06430801 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, below the 2,383-participant average among 105 other Crohn's Disease trials with a reported enrollment target (50% lower).

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 4 interventions - of which IV Tulisokibart is the first listed.

NCT06430801 names 20 study sites across 6 states, led by California, Colorado, Arizona.

Frequently Asked Questions

What is clinical trial NCT06430801 about?

NCT06430801 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)". The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical...

What is the current status of trial NCT06430801?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2024-06-05. Estimated completion is 2029-11-12.

What conditions does trial NCT06430801 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT06430801?

The interventions under investigation include: IV Tulisokibart (DRUG), SC Tulisokibart (DRUG), IV Placebo (OTHER), SC Placebo (OTHER).

Who is sponsoring clinical trial NCT06430801?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06430801 being conducted?

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

Learn More About Clinical Trials

Similar trials for Crohn's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06430801's enrollment target sits among peer trials

1,200 7th of 105 higher than 99 of 105 other Crohn's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn's Disease 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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More recruiting context for NCT06430801

Source: ClinicalTrials.gov NCT06430801, the US trial registry maintained by the National Library of Medicine. NCT06430801 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.