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Crohn DiseasePhase 3NCT06651281

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

A Phase 3 study testing Tulisokibart in people with Crohn Disease and Colitis, Ulcerative, run by Merck Sharp & Dohme LLC at 37 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Crohn Disease, Colitis, Ulcerative
What is being tested?
Tulisokibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,380 participants
Where
37 sitesin 7 countries
Study dates
25 Nov 2024to 17 Dec 2037
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

37 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

37 sites in 7 countries

Poland14 sites, 12 recruiting

  • Vita Longa Sp. Zoo ( Site 2213)

    Katowice, Silesian Voivodeship, 40-748

    Study Coordinator, +48322029715

    Recruiting

  • Krakowskie Centrum Medyczne ( Site 2210)

    Krakow, Lesser Poland Voivodeship, 31-501

    Study Coordinator, +48124231722

    Recruiting

  • Bonifraterskie Centrum Medyczne ( Site 2207)

    Lodz, Łódź Voivodeship, 93-357

    Study Coordinator, +48 42 685 51 39

    Recruiting

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)

    Lublin, Lublin Voivodeship, 20-059

    Study Coordinator, +48882935706

    Recruiting

  • Medrise Sp. z o.o. ( Site 2200)

    Lublin, Lublin Voivodeship, 20-582

    Study Coordinator, +48572300747

    Recruiting

  • Rivermed Sp. z.o.o. ( Site 2206)

    Poznan, Greater Poland Voivodeship, 61-441

    Study Coordinator, + 48 692 132 092

    Recruiting

  • Sonomed Sp. z o. o. ( Site 2203)

    Szczecin, West Pomeranian Voivodeship, 71-685

    Study Coordinator, +91 820 11 10

    Recruiting

  • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)

    Warsaw, Masovian Voivodeship, 00-189

    Study Coordinator, +48663097750

    Recruiting

  • Vivamed Sp. z o.o. ( Site 2201)

    Warsaw, Masovian Voivodeship, 03-580

    Study Coordinator, +48226792883

    Recruiting

  • WIP Warsaw IBD Point Professor Kierkus ( Site 2209)

    Warsaw, Masovian Voivodeship, 04-501

    Study Coordinator, +48500111648

    Recruiting

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

    Study Coordinator, +48542334000

    Recruiting

  • Centrum Medyczne Oporow ( Site 2212)

    Wroclaw, Lower Silesian Voivodeship, 52-416

    Study Coordinator, +48717127077

    Recruiting

  • Melita Medical Sp. z o.o. ( Site 2204)

    Wroclaw, Lower Silesian Voivodeship, 53-611

    Active, not recruiting

  • Przychodnia Futuremeds Wroclaw ( Site 2211)

    Wroclaw, Lower Silesian Voivodeship, 53-673

    Active, not recruiting

Other trials in Poland

United States12 sites, 12 recruiting

  • Connecticut Clinical Research Institute ( Site 0297)

    Bristol, Connecticut, 06010

    Study Coordinator, 860-585-3000

    Recruiting

  • University of Virginia Health System ( Site 0291)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-243-3090

    Recruiting

  • GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)

    Garland, Texas, 75044

    Study Coordinator, 972-265-8201

    Recruiting

  • BVL Research - Kansas ( Site 0292)

    Liberty, Missouri, 64068

    Study Coordinator, 816-222-4241

    Recruiting

  • GI Alliance - Lubbock ( Site 0288)

    Lubbock, Texas, 79410

    Study Coordinator, 806-793-3141

    Recruiting

  • Caprock Gastro Research ( Site 0293)

    Lubbock, Texas, 79424

    Study Coordinator, 808-239-1823

    Recruiting

  • New York Gastroenterology Associates ( Site 0253)

    New York, New York, 10075

    Study Coordinator, 212-369-2490

    Recruiting

  • Southern Star Research Institute ( Site 0299)

    San Antonio, Texas, 78229

    Study Coordinator, 210-581-2812

    Recruiting

  • GI Alliance - Southlake ( Site 0298)

    Southlake, Texas, 76092-9167

    Study Coordinator, 817-424-1525

    Recruiting

  • Washington Gastroenterology - Tacoma ( Site 0295)

    Tacoma, Washington, 98405

    Study Coordinator, 425-452-8547

    Recruiting

  • Tyler Research Institute ( Site 0294)

    Tyler, Texas, 75701

    Study Coordinator, 903-630-6211

    Recruiting

  • St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)

    Ypsilanti, Michigan, 48197

    Study Coordinator, 734-418-7736

    Recruiting

Other trials in United States

France4 sites, 4 recruiting

  • Hopital Claude Huriez CHRU LILLE ( Site 1004)

    Lille, Nord, 59037

    Study Coordinator, +33320445620

    Recruiting

  • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)

    Neuilly-sur-Seine, Hauts-de-Seine, 92200

    Study Coordinator, +33141430573

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)

    Nice, Alpes-Maritimes, 06202

    Study Coordinator, +33 (0)4 92 03 93 66

    Recruiting

  • CHRU De Nancy - Hopital de Brabois ( Site 1001)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

    Study Coordinator, +33383157488

    Recruiting

Other trials in France

Czechia2 sites, 2 recruiting

  • Vojenská Nemocnice Brno-Internal department ( Site 0701)

    Brno, Brno-mesto, 615 00

    Study Coordinator, +420 973 445 520

    Recruiting

  • Hepato-Gastroenterologie HK ( Site 0700)

    Hradec Králové, 50012

    Study Coordinator, +420495218475

    Recruiting

Other trials in Czechia

Hungary2 sites, 2 recruiting

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)

    Békéscsaba, Bekes County, 5600

    Study Coordinator, +36304366675

    Recruiting

  • Semmelweis Egyetem ( Site 1400)

    Budapest, 1082

    Study Coordinator, 3614591500/52120

    Recruiting

Other trials in Hungary

United Kingdom2 sites, 1 recruiting

  • Whipps Cross University Hospital ( Site 3400)

    London, Waltham Forest, E11 1NR

    Active, not recruiting

  • MAC Research - Merseyside ( Site 3401)

    Prescot, Knowsley, L34 1BH

    Study Coordinator, (0)151 482 4700

    Recruiting

Other trials in United Kingdom

Georgia1 site, 1 recruiting

  • ARENSIA Exploratory Medicine Georgia ( Site 1104)

    Tbilisi, 0112

    Study Coordinator, +995 599 133 071

    Recruiting

Other trials in Georgia

About this study

Official title: 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.

Being tested
Tulisokibart, Placebo to tulisokibart
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TulisokibartDrug

    Also called MK-7240

    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

  • Placebo to tulisokibartDrug

    Placebo matching SC tulisokibart

Study groups in NCT06651281
Study groupRoleWhat they receive
Group 1: Low Dose UnblindedExperimentalParticipants receive a low dose subcutaneous (SC) tulisokibart regimen.
Receives: Drug: Tulisokibart
Group 2: High Dose UnblindedExperimentalParticipants receive a high dose SC tulisokibart regimen.
Receives: Drug: Tulisokibart
Group 3: High Dose BlindedExperimentalParticipants receive a blinded high dose SC tulisokibart regimen.
Receives: Drug: Tulisokibart
Group 4: Low Dose BlindedExperimentalParticipants receive a blinded low dose SC tulisokibart regimen.
Receives: Drug: Tulisokibart; Drug: Placebo to tulisokibart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience an Adverse Event (AE)

    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.

    Measured: Up to approximately 378 weeks

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Measured: Up to approximately 364 weeks

Secondary outcomes (4)

  1. Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score

    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.

    Measured: Week 364

  2. Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score

    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.

    Measured: Week 364

  3. Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)

    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.

    Measured: Week 364

  4. Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)

    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.

    Measured: Week 364

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start25 Nov 2024
  3. Primary completion17 Dec 2037 (estimated)
  4. Study completion17 Dec 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This extension study will enroll participants who choose to enter from certain studies in which they are already receiving treatment (their "parent studies"). They will enter the appropriate arm in this study that will provide the same treatment they had been receiving on their parent study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651281
Sponsor's protocol ID
7240-011
Other IDs
2024-513533-20-00, U1111-1306-6970
Status last verified
Oct 2026
First submitted
18 Oct 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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