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

NCT06651281 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 7240-0112024-513533-20-00U1111-1306-6970
• Study Type: interventional
• Target: 1,380
• Locations: 7 countries
• Sites: 37

Brief 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). 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.

Conditions

Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 378 weeks

• 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.

  Up to approximately 364 weeks

Secondary Outcomes (4)

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

  Week 364

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

  Week 364

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

  Week 364

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

  Week 364

Study Arms (4)

Group 1: Low Dose Unblinded

EXPERIMENTAL

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

Drug: Tulisokibart

Group 2: High Dose Unblinded

EXPERIMENTAL

Participants receive a high dose SC tulisokibart regimen.

Drug: Tulisokibart

Group 3: High Dose Blinded

EXPERIMENTAL

Participants receive a blinded high dose SC tulisokibart regimen.

Drug: Tulisokibart

Group 4: Low Dose Blinded

EXPERIMENTAL

Participants receive a blinded low dose SC tulisokibart regimen.

Drug: Tulisokibart; Drug: Placebo to tulisokibart

Interventions

Tulisokibart DRUG

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

Also known as: MK-7240

Group 1: Low Dose Unblinded; Group 2: High Dose Unblinded; Group 3: High Dose Blinded; Group 4: Low Dose Blinded

Placebo to tulisokibart DRUG

Placebo matching SC tulisokibart

Group 4: Low Dose Blinded

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (37)

Connecticut Clinical Research Institute ( Site 0297)

Bristol, Connecticut, 06010, United States

RECRUITING

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

Ypsilanti, Michigan, 48197, United States

RECRUITING

BVL Research - Kansas ( Site 0292)

Liberty, Missouri, 64068, United States

RECRUITING

New York Gastroenterology Associates ( Site 0253)

New York, New York, 10075, United States

RECRUITING

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

Garland, Texas, 75044, United States

RECRUITING

GI Alliance - Lubbock ( Site 0288)

Lubbock, Texas, 79410, United States

RECRUITING

Caprock Gastro Research ( Site 0293)

Lubbock, Texas, 79424, United States

RECRUITING

Southern Star Research Institute ( Site 0299)

San Antonio, Texas, 78229, United States

RECRUITING

GI Alliance - Southlake ( Site 0298)

Southlake, Texas, 76092-9167, United States

RECRUITING

Tyler Research Institute ( Site 0294)

Tyler, Texas, 75701, United States

RECRUITING

University of Virginia Health System ( Site 0291)

Charlottesville, Virginia, 22908, United States

RECRUITING

Washington Gastroenterology - Tacoma ( Site 0295)

Tacoma, Washington, 98405, United States

RECRUITING

Vojenská Nemocnice Brno-Internal department ( Site 0701)

Brno, Brno-mesto, 615 00, Czechia

RECRUITING

Hepato-Gastroenterologie HK ( Site 0700)

Hradec Králové, 50012, Czechia

RECRUITING

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

Nice, Alpes-Maritimes, 06202, France

RECRUITING

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

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

RECRUITING

CHRU De Nancy - Hopital de Brabois ( Site 1001)

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

RECRUITING

Hopital Claude Huriez CHRU LILLE ( Site 1004)

Lille, Nord, 59037, France

RECRUITING

ARENSIA Exploratory Medicine Georgia ( Site 1104)

Tbilisi, 0112, Georgia

RECRUITING

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

Békéscsaba, Bekes County, 5600, Hungary

RECRUITING

Semmelweis Egyetem ( Site 1400)

Budapest, 1082, Hungary

RECRUITING

Rivermed Sp. z.o.o. ( Site 2206)

Poznan, Greater Poland Voivodeship, 61-441, Poland

RECRUITING

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

Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

RECRUITING

Krakowskie Centrum Medyczne ( Site 2210)

Krakow, Lesser Poland Voivodeship, 31-501, Poland

RECRUITING

Centrum Medyczne Oporow ( Site 2212)

Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

RECRUITING

Melita Medical ( Site 2204)

Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

RECRUITING

Przychodnia Futuremeds Wroclaw ( Site 2211)

Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

RECRUITING

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

Lublin, Lublin Voivodeship, 20-059, Poland

RECRUITING

Medrise Sp. z o.o. ( Site 2200)

Lublin, Lublin Voivodeship, 20-582, Poland

RECRUITING

Centrum Zdrowia MDM ( Site 2202)

Warsaw, Masovian Voivodeship, 00-189, Poland

RECRUITING

Vivamed Sp. z o.o. ( Site 2201)

Warsaw, Masovian Voivodeship, 03-580, Poland

RECRUITING

WIP Warsaw IBD Point Professor Kierkus ( Site 2209)

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Vita Longa Sp. Zoo ( Site 2213)

Katowice, Silesian Voivodeship, 40-748, Poland

RECRUITING

Sonomed Sp. z o. o. ( Site 2203)

Szczecin, West Pomeranian Voivodeship, 71-685, Poland

RECRUITING

Bonifraterskie Centrum Medyczne ( Site 2207)

Lodz, Łódź Voivodeship, 93-357, Poland

RECRUITING

Whipps Cross University Hospital ( Site 3400)

London, England, E11 1NR, United Kingdom

ACTIVE NOT RECRUITING

MAC Research - Merseyside ( Site 3401)

Prescot, Knowsley, L34 1BH, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in "Group 1: Low Dose Unblinded" and "Group 2: High Dose Unblinded" received open-label treatment on their parent studies, and will remain unblinded on this extension study. Participants in "Group 3: High Dose Blinded" and "Group 4: Low Dose Blinded" were all blinded on their parent studies, and will remain blinded on this extension study until after regulatory approval or market authorization in the United States or European Medicines Agency, per sponsor discretion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 17, 2037
• Study Completion (Estimated): December 17, 2037
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CZ (2); PL (14); GB (2); HU (2); US (12); FR (4); GE (1)