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 June 30, 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.
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
Osijek, Osjecko Baranjska Zupanija, Croatia
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
Gent, Oost Vlaanderen, Belgium
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
Vina Del Mar, Valparaiso, Chile
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Huizhou, Guangdong, China
Shiyan, Hubei, China
Suining, Sichuan, China
Taizhou, Zhejiang, China
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Hiroshima, , Japan
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Dallas, Texas, United States
Zhenjiang, Jiangsu, China
Shanghai, Shanghai, China
Kfar Saba, , Israel
Petah Tikva, , Israel
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Lancaster, California, United States
Orange, California, United States
Indianapolis, Indiana, United States
Kfar Saba, , Israel
Petah Tikva, , Israel
Kyoto, , Japan
Lviv, Lvivska Oblast, Ukraine
Vinnytsya, Vinnytska Oblast, Ukraine
Lutsk, Volynska Oblast, Ukraine
Leuven, Vlaams Brabant, Belgium
Calgary, Alberta, Canada
Zagreb, Grad Zagreb, Croatia
Camarillo, California, United States
Coronado, California, United States
Chicago, Illinois, United States
Dallas, Texas, United States
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
Nijmegen, Gelderland, Netherlands
Portimão, Faro, Portugal
Kyiv, Kyivska Oblast, Ukraine
Huddersfield, England, United Kingdom
Liberty, Missouri, United States
Saint Louis, Missouri, United States
Ludwighafen Am Rhein, Rheinland Pfalz, Germany
Nishinomiya, Hyogo, Japan
Bunkyō, Tokyo, Japan
Rotterdam, Zuid Holland, Netherlands
Stockholm, Stockholms Lan, Sweden
Zhu Bei City, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Kyiv, Kyivska Oblast, Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
London, England, United Kingdom
Zagreb, Grad Zagreb, Croatia
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
Besançon, Doubs, France
Toulouse, Haute Garonne, France
Lille, Nord, France
Amiens, Somme, France
Brandenburg, , Germany
Békéscsaba, Bekescsaba, Hungary
Milano, , Italy
Kawagoe, Saitama, Japan
Shimizu, Shizuoka, Japan
Minato, Tokyo, Japan
Shinjyuku Ku, Tokyo, Japan
Amsterdam, Noord Holland, Netherlands
Lisboa, , Portugal
București, Bucuresti, Romania
Richmond, Virginia, United States
Concord, New South Wales, Australia
Oakville, Ontario, Canada
Beijing, Beijing, China
Xiamen, Fujian, China
Dongguan, Guangdong, China
Shenzhen, Guangdong, China
Cheng Du, Sichuan, China
Pessac, Aquitaine, France
Marseille, Bouches Du Rhone, France
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Neuilly Sur Seine, Hauts De Seine, France
Montpellier, Languedoc Roussillon, France
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Paris, , France
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Budapest, , Hungary
Rome, Lazio, Italy
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Roma, , Italy
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Mitaka, Tokyo, Japan
Yamagata, , Japan
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Salzburg, , Austria
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London, Ontario, Canada
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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
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Lower Hutt, Wellington, New Zealand
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Szczecin, Zachodniopomorskie, Poland
Szczecin, Zachodniopomorskie, Poland
Bratislava, Bratislavsky Kraj, Slovakia
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Linköping, Ostergotlands Lan, Sweden
Danderyd, Stockholms Lan, Sweden
Ankara, , Turkey
Exeter, Devon, United Kingdom
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Wuhan, Hubei, China
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Leipzig, Sachsen, Germany
Afula, , Israel
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Nagoya,, Aichi, Japan
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Hamamatsu, Shizuoka, Japan
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Kuching, Sarawak, Malaysia
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Badalona, Barcelona, Spain
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Madrid, , Spain
Pontevedra, , Spain
Valencia, , Spain
Zaragoza, , Spain
Ankara, , Turkey
Anaheim, California, United States
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Eger, Heves, Hungary
Messina, , Italy
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Istanbul, , Turkey
West Midlands, Walsall, United Kingdom
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Barrie, Ontario, Canada
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Ulm, Bayern, Germany
Duisburg, Nordrhein Westfalen, Germany
Johor Bahru, Johor, Malaysia
Lima, , Peru
Singapore, Central Singapore, Singapore
Valencia, , Spain
Istanbul, , Turkey
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Leon, Guanajuato, Mexico
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Leiria, , Portugal
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Evanston, Illinois, United States
München, Bayern, Germany
Berlin, , Germany
Napoles, Napoli, Italy
Shinjuku, Tokyo, Japan
Oaxaca De Juarez, Oaxaca, Mexico
Nitra, Nitriansky Kraj, Slovakia
Oxford, Oxfordshire, United Kingdom
Oklahoma City, Oklahoma, United States
Innsbruck, Tirol, Austria
Medellín, Antioquia, Colombia
Monteria, Cordoba, Colombia
Pereira., Risaralda, Colombia
Copenhagen, Hovedstaden, Denmark
Odense C, Syddanmark, Denmark
Valence, Drome, France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Hksar, , Hong Kong
Budapest, , Hungary
Lima, , Peru
Torun, Kujawsko Pomorskie, Poland
Poznań, Wielkopolskie, Poland
Torrejón De Ardoz, Madrid, Spain
Clayton, Victoria, Australia
Concepción, Biobio, Chile
Hackensack, New Jersey, United States
Cali., Valle Del Cauca, Colombia
Ulm, Bayern, Germany
Dunedin, Otago, New Zealand
Santa Cruz De Tenerife, , Spain
St.Gallen, Sankt Gallen, Switzerland
Antalya, , Turkey
Houston, Texas, United States
Vienna, Wien, Austria
Vaughan, Ontario, Canada
Aurora, Colorado, United States
Nanjing, Jiangsu, China
Xian, Shaanxi, China
Athens, Attiki, Greece
Békéscsaba, Bekescsaba, Hungary
Milano, Lombardia, Italy
Palermo, Sicilia, Italy
Roma, , Italy
Kaunas, Kauno Apskritis, Lithuania
Amsterdam, Noord Holland, Netherlands
Bucharest, Bucuresti, Romania
Zrenjanin, Srednjebanatski Okrug, Serbia
Banska Bystrica, Banskobystricky Kraj, Slovakia
Barcelona, Cataluna, Spain
Ankara, , Turkey
Ivano Frankivsk, Ivano Frankivska Oblast, Ukraine
Lviv, Lvivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsya, Vinnytska Oblast, Ukraine
New Westminster, British Columbia, Canada
Temuco, Araucania, Chile
Hradec Kralove, , Czechia
Presov, Presovsky Kraj, Slovakia
Batumi, Ajaria, Georgia
Belgrade, Beograd, Serbia
Presov, Presovsky Kraj, Slovakia
London, London, City Of, United Kingdom
Bristol, South Gloucestershire, United Kingdom
Tampa, Florida, United States
Tatabánya, Komarom Esztergom, Hungary
Bari, Puglia, Italy
Tucson, Arizona, United States
Lethbridge, Alberta, Canada
Vilnius, , Lithuania
Tbilisi, Ajaria, Georgia
Boston, Massachusetts, United States
Levis, Quebec, Canada
Praha, , Czechia
Joensuu, Pohjois Karjala, Finland
Remscheid, Nordrhein Westfalen, Germany
Zhu Bei City, Hsinchu, Taiwan
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported