A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Launched by MERCK SHARP & DOHME LLC · May 21, 2024
Trial Information
Current as of March 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called tulisokibart, which is being tested for its effectiveness and safety in treating people with moderate to severe Crohn's disease. Crohn's disease is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The researchers want to find out if tulisokibart can help patients achieve better health, measured by improvements in their symptoms and in exams of their intestines over a period of 12 to 52 weeks.
To participate in the trial, individuals must be at least 18 years old and have been diagnosed with Crohn's disease for at least three months. They should have had inadequate response or intolerance to previous treatments for Crohn's disease. However, those with certain complications of Crohn's or other specific health issues may not be eligible. Participants will receive either tulisokibart or a placebo (a substance with no active medication) and will be monitored closely throughout the study. This trial is currently recruiting participants, and it aims to provide valuable information about a potential new treatment option for Crohn's disease.
Gender
ALL
Eligibility criteria
- The main inclusion and exclusion criteria include but are not limited to the following:
- Inclusion Criteria:
- • Has had a diagnosis of CD at least 3 months before study.
- • Has moderately to severely active CD.
- • Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- • Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
- Exclusion Criteria:
- • Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- • Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- • Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- • Has current stoma or need for colostomy or ileostomy.
- • Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- • Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
- • Has surgical bowel resection within 3 months of study.
- • Has prior or current gastrointestinal dysplasia.
- • Has chronic infection requiring ongoing antimicrobial treatment.
- • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
- • Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- • Has active tuberculosis.
- • Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Quebec, , Canada
Toronto, Ontario, Canada
Palermo, Sicilia, Italy
Athens, Attiki, Greece
Dothan, Alabama, United States
Colorado Springs, Colorado, United States
Clearwater, Florida, United States
Macon, Georgia, United States
New York, New York, United States
Charlotte, North Carolina, United States
Mentor, Ohio, United States
Providence, Rhode Island, United States
Mansfield, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Tacoma, Washington, United States
Wonju, Kang Won Do, Korea, Republic Of
Busan, Pusan Kwangyokshi, Korea, Republic Of
Haeundae Gu, Pusan Kwangyokshi, Korea, Republic Of
Dongjak Gu, Seoul, Korea, Republic Of
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Daejeon, Taejon Kwangyokshi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Milano, Lombardia, Italy
Gurnee, Illinois, United States
Topeka, Kansas, United States
Clinton Township, Michigan, United States
Sakura, Chiba, Japan
Kurume, Fukuoka, Japan
Hamamatsu, Shizuoka, Japan
Kagoshima, , Japan
Seoul, , Korea, Republic Of
Bellevue, Washington, United States
Tokyo, , Japan
Toyama, , Japan
Seoul, , Korea, Republic Of
Vienna, Wien, Austria
Margate, Florida, United States
Orlando, Florida, United States
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Ashkelon, , Israel
Haifa, , Israel
Sapporo, Hokkaido, Japan
Kamakura, Kanagawa, Japan
Chuo, Tokyo, Japan
Kyoto, , Japan
Osaka, , Japan
Saga, , Japan
Seoul, , Korea, Republic Of
St.Gallen, Sankt Gallen, Switzerland
Hamden, Connecticut, United States
Fukuyama, Hiroshima, Japan
Hitachi, Ibaraki, Japan
Yokohama, Kanagawa, Japan
Suwon Si, Kyonggi Do, Korea, Republic Of
Basel, Basel Stadt, Switzerland
Orlando, Florida, United States
Lubbock, Texas, United States
Aurora, Colorado, United States
Zachary, Louisiana, United States
New York, New York, United States
Uniontown, Pennsylvania, United States
Nashville, Tennessee, United States
Lubbock, Texas, United States
Southlake, Texas, United States
Fuzhou, Fujian, China
Haifa, , Israel
Jerusalem, , Israel
Nagakute, Aichi, Japan
Yokohama, Kanagawa, Japan
Bern, Berne, Switzerland
Valencia, California, United States
Middletown, New York, United States
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Guangzhou, Guangdong, China
Huizhou, Guangdong, China
Shiyan, Hubei, China
Suining, Sichuan, China
Taizhou, Zhejiang, China
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Abiko, Chiba, Japan
Hiroshima, , Japan
Decatur, Georgia, United States
Ann Arbor, Michigan, United States
Dallas, Texas, United States
Zhenjiang, Jiangsu, China
Shanghai, Shanghai, China
Kfar Saba, , Israel
Petah Tikva, , Israel
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Zürich, Zurich, Switzerland
Lancaster, California, United States
Orange, California, United States
Indianapolis, Indiana, United States
Kfar Saba, , Israel
Petah Tikva, , Israel
Kyoto, , Japan
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Lutsk, Volynska Oblast, Ukraine
Calgary, Alberta, Canada
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Chicago, Illinois, United States
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Chongqing, Chongqing, China
Zhengzhou, Henan, China
Hangzhou, Zhejiang, China
Nice, Alpes Maritimes, France
Vandoeuvre Les Nancy, Meurthe Et Moselle, France
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Tsu, Mie, Japan
Kofu, Yamanashi, Japan
Okayama, , Japan
Osaka, , Japan
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Portimão, Faro, Portugal
Kyiv, Kyivska Oblast, Ukraine
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Rotterdam, Zuid Holland, Netherlands
Stockholm, Stockholms Lan, Sweden
Zhu Bei City, Hsinchu, Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Kyiv, Kyivska Oblast, Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
London, England, United Kingdom
Great Neck, New York, United States
Barrie, Quebec, Canada
Zhenjiang, Jiangsu, China
Mitato, Tokyo, Japan
Shinjuku, Tokyo, Japan
Bucharest, Bucuresti, Romania
Timisoara, Timis, Romania
Basel, Basel Stadt, Switzerland
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Doncaster, England, United Kingdom
Washington, District Of Columbia, United States
Charlotte, North Carolina, United States
Shijiazhuang, Hebei, China
Nantes, Loire Atlantique, France
Minden, Nordrhein Westfalen, Germany
Holon, , Israel
Rozzano, Lombardia, Italy
Tilburg, Noord Brabant, Netherlands
Groningen, , Netherlands
Cluj Napoca, Cluj, Romania
Targu Mures, Mures, Romania
Ivano Frankivsk, Ivano Frankivska Oblast, Ukraine
Nanjing, Jiangsu, China
Dijon, Bourgogne, France
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Toulouse, Haute Garonne, France
Lille, Nord, France
Amiens, Somme, France
Brandenburg, , Germany
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Milano, , Italy
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Shimizu, Shizuoka, Japan
Minato, Tokyo, Japan
Shinjyuku Ku, Tokyo, Japan
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Lisboa, , Portugal
București, Bucuresti, Romania
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Oakville, Ontario, Canada
Beijing, Beijing, China
Xiamen, Fujian, China
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Cheng Du, Sichuan, China
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Maebashi, Gunma, Japan
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Tychy, Slaskie, Poland
Lisboa, , Portugal
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Plumstead, Western Cape, South Africa
Quebec, , Canada
Clive, Iowa, United States
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Roeselare, West Vlaanderen, Belgium
Santiago, Region M. De Santiago, Chile
Wuxi, Jiangsu, China
Koln, Nordrhein Westfalen, Germany
Gyongyos, Heves, Hungary
Ampang, Selangor, Malaysia
Uden, Noord Brabant, Netherlands
Rotterdam, Zuid Holland, Netherlands
Lower Hutt, Wellington, New Zealand
Jelenia Gora, Dolnoslaskie, Poland
Lodz, Lodzkie, Poland
Szczecin, Zachodniopomorskie, Poland
Szczecin, Zachodniopomorskie, Poland
Bratislava, Bratislavsky Kraj, Slovakia
Cape Town, Western Cape, South Africa
Linköping, Ostergotlands Lan, Sweden
Danderyd, Stockholms Lan, Sweden
Ankara, , Turkey
Exeter, Devon, United Kingdom
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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