A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Launched by MERCK SHARP & DOHME LLC · Sep 18, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called tulisokibart (MK-7240) to see if it is effective and safe for people with moderately to severely active ulcerative colitis, a condition that causes inflammation in the digestive tract. The researchers want to find out if tulisokibart can help more patients achieve clinical remission, which means their symptoms improve significantly, compared to a placebo (a dummy treatment) after 12 and 52 weeks of treatment.
To participate in the trial, individuals must be at least 16 years old and have been diagnosed with ulcerative colitis for at least three months. They should also have had insufficient response to other treatments or specific complications related to their ulcerative colitis. Participants will receive either the study medication or a placebo during the trial and will be monitored closely for any side effects. It's important to note that certain health conditions and treatments may exclude someone from participating, so potential volunteers will need to meet specific criteria before joining the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
- • Has moderately to severely active UC
- • Weight ≥40 kg
- * Satisfies at least 1 of the following criteria:
- • Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
- • Protocol specified corticosteroid dependence
- • Has been intolerant to 1 or more protocol-specified UC treatments
- • Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
- • Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority
- • A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), 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, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
- Exclusion Criteria:
- • Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
- • Has a current diagnosis of fulminant colitis and/or toxic megacolon
- • Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is \~10 cm from the anal margin)
- • Has a current or impending need for colostomy or ileostomy
- • Has had a total proctocolectomy or partial colectomy
- • Has received fecal microbial transplantation within 4 weeks before randomization
- • Has had UC exacerbation requiring hospitalization within 2 weeks before screening
- • Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- • Has any active or serious infections without resolution after adequate treatment
- • Has had cytomegalovirus infection that resolved less than 4 weeks before screening
- • Has a transplanted organ which requires continued immunosuppression
- • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
- • Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
- • Has confirmed or suspected COVID-19
- • Has a history of drug or alcohol abuse within 6 months prior to screening
- • Has had major surgery within 3 months before screening or has a major surgery planned during the study
- • Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
- • Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
- • Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
- • Has received protocol-specified prohibited medications
- • Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (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)
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Chesterfield, Michigan, United States
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Valdivia, Los Rios, Chile
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Ramat Gan, , Israel
Seoul, , Korea, Republic Of
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Toyama, , Japan
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Kyoto, , Japan
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Bern, Berne, Switzerland
Haifa, , Israel
Sapporo, Hokkaido, Japan
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Jerusalem, , Israel
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Clinton Township, Michigan, United States
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Asahikawa, Hokkaido, Japan
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Fukuoka, , Japan
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Abiko, Chiba, Japan
Kurume, Fukuoka, Japan
Kanazawa, Ishikawa, Japan
Minato Ku, Tokyo, Japan
Minato, Tokyo, Japan
Mitaka Shi, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Fukui, , Japan
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Tilburg, Noord Brabant, Netherlands
Wroclaw, Dolnoslaskie, Poland
Braga, , Portugal
Viana Do Castelo, , Portugal
Zhu Bei City, , Taiwan
London, England, United Kingdom
Athens, Attiki, Greece
Mar Del Plata, Buenos Aires, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Wanzhou, Chongqing, China
Zhengzhou, Henan, China
Shanghai, Shanghai, China
Ashkelon, , Israel
Milano, Lombardia, Italy
Lisboa, , Portugal
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Negrar, Verona, Italy
Kashiwa, Chiba, Japan
Bunkyō, Tokyo, Japan
Utrecht, , Netherlands
Braga, , Portugal
Changhua County, Changhua, Taiwan
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Xi'an, Shaanxi, China
Minden, Nordrhein Westfalen, Germany
Kiel, Schleswig Holstein, Germany
Sapporo, Hokkaido, Japan
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Uden, Noord Brabant, Netherlands
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Rosario, Santa Fe, Argentina
Beijing, Beijing, China
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Nice, Alpes Maritimes, France
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Hitachi, Ibaraki, Japan
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Ruse, , Bulgaria
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Madrid, , Spain
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Hradec Kralove, , Czechia
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Brandenburg, , Germany
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Paris, , France
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Hamilton, Waikato, New Zealand
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Frankfurt Am Main, Hessen, Germany
Duisburg, Nordrhein Westfalen, Germany
Leipzig, Sachsen, Germany
Mohács, Baranya, Hungary
Rome, Roma, Italy
Milano, , Italy
Nagakute, Aichi, Japan
Asahikawa, Hokkaido, Japan
Shimizu, Shizuoka, Japan
Wroclaw, Dolnoslaskie, Poland
Zrenjanin, Srednjebanatski Okrug, Serbia
Banska Bystrica, Banskobystricky Kraj, Slovakia
London, Ontario, Canada
Montreal, Quebec, Canada
Quebec, , Canada
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Split, Splitsko Dalmatinska Zupanija, Croatia
Kecskemét, Bacs Kiskun, Hungary
Eger, Heves, Hungary
Budapest, , Hungary
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Lørenskog, Akershus, Norway
Warsawa, Mazowieckie, Poland
Belgrade, Beograd, Serbia
Boston, Massachusetts, United States
Pereira., Risaralda, Colombia
Hamamatsu, Shizuoka, Japan
Oslo, , Norway
Vinnytsia, Vinnytska Oblast, Ukraine
Kyiv, , Ukraine
Praha, Praha 4, Czechia
Munich, Bayern, Germany
Slovakia, Banskobystricky Kraj, Slovakia
Kyiv, Kyivska Oblast, Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Southampton, Hampshire, United Kingdom
Anaheim, California, United States
Richmond, Virginia, United States
Soweto, Gauteng, South Africa
Lutsk, Volynska Oblast, Ukraine
Sofia, , Bulgaria
Hefei, Anhui, China
Ulm, Baden Wurttemberg, Germany
Oaxaca, , Mexico
Vinnytsya, Vinnytska Oblast, Ukraine
Rome, Roma, Italy
Tlajumulco De Zuniga, Jalisco, Mexico
Mexico City, , Mexico
Lisboa, , Portugal
Johannesburg, Gauteng, South Africa
Louisville, Kentucky, United States
Pereira., Risaralda, Colombia
Kaunas, Kauno Apskritis, Lithuania
Guadalajara, Jalisco, Mexico
Belgrade, Beograd, Serbia
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Medellin, Antioquia, Colombia
Zagreb, Grad Zagreb, Croatia
Paris, , France
Tbilisi, , Georgia
Kragujevac, Beograd, Serbia
Tbilisi, , Georgia
Tbilisi, , Georgia
Houston, Texas, United States
Liepaja, , Latvia
Ulm, Baden Wurttemberg, Germany
Tatabánya, Komarom Esztergom, Hungary
Madrid, Madrid, Comunidad De, Spain
St.Gallen, Sankt Gallen, Switzerland
Los Angeles, California, United States
Aurora, Colorado, United States
Houston, Texas, United States
Vienna, Wien, Austria
Vaughan, Ontario, Canada
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Xian, Shaanxi, China
Medellín, Antioquia, Colombia
Athens, Attiki, Greece
Békéscsaba, Bekescsaba, Hungary
Milano, Lombardia, Italy
Palermo, Sicilia, Italy
Merida, Yucatan, Mexico
Bucharest, Bucuresti, Romania
Brezno, Banskobystricky Kraj, Slovakia
Ivano Frankivsk, Ivano Frankivska Oblast, Ukraine
Lviv, Lvivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Vinnytsya, Vinnytska Oblast, Ukraine
Lutsk, Volynska Oblast, Ukraine
Englewood, Colorado, United States
Batumi, Ajaria, Georgia
Tampa, Florida, United States
Farmington Hills, Michigan, United States
Levis, Quebec, Canada
Santiago., Region M. De Santiago, Chile
Brno, Brno Mesto, Czechia
Scottsdale, Arizona, United States
Lethbridge, Alberta, Canada
Miami, Florida, United States
Sofia, , Bulgaria
Montreal, Quebec, Canada
Praha, , Czechia
Tbilisi, Ajaria, Georgia
Mexico City, Distrito Federal, Mexico
Madrid, , Spain
Madrid, , Spain
Torrejón De Ardoz, , Spain
Valencia, , Spain
Zhu Bei City, Hsinchu, Taiwan
Bristol, , United Kingdom
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