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Search / Trial NCT06430801

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 27, 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.

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

Ramat Gan, , Israel

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

Sapporo, Hokkaido, Japan

Morioka, Iwate, Japan

Zürich, Zurich, Switzerland

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

Reims Cedex, Champagne Ardenne, France

Clichy, Hauts De Seine, France

Neuilly Sur Seine, Hauts De Seine, France

Montpellier, Languedoc Roussillon, France

Pierre Bénite, Rhone, France

Creteil, Val De Marne, France

Paris, , France

Kiel, Schleswig Holstein, Germany

Veszprém, Veszprem, Hungary

Budapest, , Hungary

Rome, Lazio, Italy

Negrar Di Valpolicella, Verona, Italy

Bologna, , Italy

Roma, , Italy

Kawasaki, Kanagawa, Japan

Mitaka, Tokyo, Japan

Yamagata, , Japan

Utrecht, , Netherlands

Viana Do Castelo, , Portugal

Bucuresti, , Romania

Salzburg, , Austria

Nashville, Tennessee, United States

Melbourne, Victoria, Australia

Mississauga, Ontario, Canada

Hefei, Anhui, China

Chongqing, Chongqing, China

Nimes, Gard, France

Ulm, Bayern, Germany

Maebashi, Gunma, Japan

Guimaraes, Braga, Portugal

Viseu, , Portugal

Singapore, South East, Singapore

Santiago, Region M. De Santiago, Chile

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Xiamen, Fujian, China

Shenzhen, Guangdong, China

Shijiazhuang, Hebei, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Xian, Shaanxi, China

Shanghai, Shanghai, China

Kunming, Yunnan, China

Tampere, Pirkanmaa, Finland

Turku, Varsinais Suomi, Finland

Kremlin Bicetre, Ile De France, France

Athens, Attiki, Greece

Nikaia Piraeus, Attiki, Greece

Thessaloniki, Kentriki Makedonia, Greece

Heraklion, Kriti, Greece

Pontedera, Pisa, Italy

Nagoya, Aichi, Japan

Sendai, Miyagi, Japan

Kagoshima, , Japan

London, Ontario, Canada

Inverness, Florida, United States

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Adelaide, South Australia, Australia

Vancouver, British Columbia, Canada

Xiamen, Fujian, China

Amiens, Somme, France

Pforzheim, Baden Wurttemberg, Germany

München, Bayern, Germany

Rostock, Mecklenburg Vorpommern, Germany

Hannover, Niedersachsen, Germany

Münster, Nordrhein Westfalen, Germany

Budapest, , Hungary

Nagakute, Aichi, Japan

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Kanazawa, Ishikawa, Japan

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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

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Szczecin, Zachodniopomorskie, Poland

Szczecin, Zachodniopomorskie, Poland

Bratislava, Bratislavsky Kraj, Slovakia

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Ankara, , Turkey

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Wuhan, Hubei, China

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Lüneburg, Niedersachsen, Germany

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Afula, , Israel

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Madrid, , Spain

Pontevedra, , Spain

Valencia, , Spain

Zaragoza, , Spain

Ankara, , Turkey

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Messina, , Italy

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Merida, Yucatan, Mexico

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Duisburg, Nordrhein Westfalen, Germany

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Lima, , Peru

Singapore, Central Singapore, Singapore

Valencia, , Spain

Istanbul, , Turkey

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Leon, Guanajuato, Mexico

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Leiria, , Portugal

Tucson, Arizona, United States

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

0 patients applied

Trial Officials

Medical Director

Study Director

Merck Sharp & Dohme LLC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported