Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

May 15, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Hradec Králové, Czechia, 50012
        • Recruiting
        • Hepato-Gastroenterologie HK ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +420495218475
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 615 00
        • Recruiting
        • Vojenská Nemocnice Brno-Internal department ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 973 445 520
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 (0)4 92 03 93 66
    • Hauts-de-Seine
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • Recruiting
        • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +33141430573
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • Recruiting
        • CHRU De Nancy - Hopital de Brabois ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +33383157488
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez CHRU LILLE ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320445620
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • ARENSIA Exploratory Medicine Georgia ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 599 133 071
  • Hungary
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 3614591500/52120
    • Bekes County
      • Békéscsaba, Bekes County, Hungary, 5600
        • Recruiting
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)
        • Contact:
          • Study Coordinator
          • Phone Number: +36304366675
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-441
        • Recruiting
        • Rivermed Sp. z.o.o. ( Site 2206)
        • Contact:
          • Study Coordinator
          • Phone Number: + 48 692 132 092
    • Kuyavian-Pomeranian Voivodeship
      • Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800
        • Recruiting
        • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
        • Contact:
          • Study Coordinator
          • Phone Number: +48542334000
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • Krakowskie Centrum Medyczne ( Site 2210)
        • Contact:
          • Study Coordinator
          • Phone Number: +48124231722
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
        • Recruiting
        • Centrum Medyczne Oporow ( Site 2212)
        • Contact:
          • Study Coordinator
          • Phone Number: +48717127077
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
        • Active, not recruiting
        • Melita Medical Sp. z o.o. ( Site 2204)
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
        • Active, not recruiting
        • Przychodnia Futuremeds Wroclaw ( Site 2211)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-059
        • Recruiting
        • 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)
        • Contact:
          • Study Coordinator
          • Phone Number: +48882935706
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • Recruiting
        • Medrise Sp. z o.o. ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: +48572300747
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 03-580
        • Recruiting
        • Vivamed Sp. z o.o. ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +48226792883
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • Recruiting
        • WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
        • Contact:
          • Study Coordinator
          • Phone Number: +48500111648
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • Recruiting
        • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +48663097750
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-748
        • Recruiting
        • Vita Longa Sp. Zoo ( Site 2213)
        • Contact:
          • Study Coordinator
          • Phone Number: +48322029715
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-685
        • Recruiting
        • Sonomed Sp. z o. o. ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +91 820 11 10
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-357
        • Recruiting
        • Bonifraterskie Centrum Medyczne ( Site 2207)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 42 685 51 39
  • United Kingdom
    • England
      • London, England, United Kingdom, E11 1NR
        • Active, not recruiting
        • Whipps Cross University Hospital ( Site 3400)
    • Knowsley
      • Prescot, Knowsley, United Kingdom, L34 1BH
        • Recruiting
        • MAC Research - Merseyside ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: (0)151 482 4700
  • United States
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Recruiting
        • Connecticut Clinical Research Institute ( Site 0297)
        • Contact:
          • Study Coordinator
          • Phone Number: 860-585-3000
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-418-7736
    • Missouri
      • Liberty, Missouri, United States, 64068
        • Recruiting
        • BVL Research - Kansas ( Site 0292)
        • Contact:
          • Study Coordinator
          • Phone Number: 785-217-6559
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates ( Site 0253)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-369-2490
    • Texas
      • Garland, Texas, United States, 75044
        • Recruiting
        • GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-265-8201
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • GI Alliance - Lubbock ( Site 0288)
        • Contact:
          • Study Coordinator
          • Phone Number: 806-793-3141
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Caprock Gastro Research ( Site 0293)
        • Contact:
          • Study Coordinator
          • Phone Number: 808-239-1823
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute ( Site 0299)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-581-2812
      • Southlake, Texas, United States, 76092-9167
        • Recruiting
        • GI Alliance - Southlake ( Site 0298)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-424-1525
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute ( Site 0294)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-630-6211
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System ( Site 0291)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-243-3090
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Washington Gastroenterology - Tacoma ( Site 0295)
        • Contact:
          • Study Coordinator
          • Phone Number: 425-452-8547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
  • The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
  • A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
  • A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
  • A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Exclusion Criteria:

  • Has prematurely discontinued study intervention in their parent study
  • Has received any protocol-specified prohibited medications during their parent study
  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Low Dose Unblinded
Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
Drug: Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • MK-7240
Experimental: Group 2: High Dose Unblinded
Participants receive a high dose SC tulisokibart regimen.
Drug: Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • MK-7240
Experimental: Group 3: High Dose Blinded
Participants receive a blinded high dose SC tulisokibart regimen.
Drug: Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • MK-7240
Experimental: Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen.
Drug: Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • MK-7240
Drug: Placebo to tulisokibart
Placebo matching SC tulisokibart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 378 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Up to approximately 378 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 364 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 364 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Time Frame: Week 364
The percentage of participants who enrolled in their parent study with Crohn's disease who achieve clinical remission, as defined by CDAI score <150, at Week 364 will be presented.
Week 364
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
Time Frame: Week 364
The percentage of participants who enrolled in their parent study with Crohn's disease achieving clinical remission at Week 364 per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline will be presented.
Week 364
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)
Time Frame: Week 364
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 364
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
Time Frame: Week 364
The Simplified Endoscopic Score for Crohn's Disease (SES-CD) measures ileocolonoscopic findings in Crohn's Disease. Each segment of the ileo-colon (terminal ileum; ascending, transverse, and descending colon; rectum) is scored from 0 (normal or inactive disease) to 12 (severe disease; no more than one segment can have a score of 12, in which case the other 4 segments must each be ≤11), and the scores summed to produce an SES-CD ranging from 0 (overall least severe disease) to 56 (overall most severe disease). Endoscopic remission is defined as an SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable, as scored by central reader.
Week 364

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

December 17, 2037

Study Completion (Estimated)

December 17, 2037

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-011
  • U1111-1306-6970 (Registry Identifier: UTN)
  • 2024-513533-20-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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