A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
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:
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:
La Jolla, California 92037, United States
Orange, California 92868, United States
Aurora, Colorado 80045, United States
Littleton, Colorado 80120, United States
New Haven, Connecticut 06510, United States
Washington D.C., District of Columbia 20009, United States
Gainesville, Florida 32610, United States
Miami, Florida 33134, United States
Atlanta, Georgia 30342, United States
Louisville, Kentucky 40202, United States
Baton Rouge, Louisiana 70809, United States
New Orleans, Louisiana 70112, United States
Glen Burnie, Maryland 21061, United States
Boston, Massachusetts 02114, United States
Clinton Township, Michigan 48038, United States
Farmington Hills, Michigan 48334, United States
New York, New York 10016, United States
Chapel Hill, North Carolina 27514, United States
Greenville, North Carolina 27834, United States
Philadelphia, Pennsylvania 19104, United States
Orangeburg, South Carolina 29118, United States
Houston, Texas 77030, United States
San Antonio, Texas 78212, United States
Seattle, Washington 98195, United States
Mar del Plata, Buenos Aires 7600, Argentina
Quilmes, Buenos Aires F.D. B1878DVB, Argentina
San Miguel de Tucumán, Tucumán Province T4000IKO, Argentina
Sydney, New South Wales 2139, Australia
Adelaide, South Australia 5000, Australia
Vienna, State of Vienna 1090, Austria
Leuven, Vlaams-Brabant 3000, Belgium
Juiz de Fora, Minas Gerais 36025-290, Brazil
São José do Rio Preto, São Paulo 15090-160, Brazil
Sofia, Sofia (stolitsa) 1618, Bulgaria
Edmonton, Alberta T5R 1W2, Canada
Lethbridge, Alberta T1J 4G9, Canada
Ontario, Ontario L6L 5L7, Canada
Lévis, Quebec G6V 3Z1, Canada
Santiago, Region M. de Santiago 8330034, Chile
Beijing, Beijing Municipality 100050, China
Beijing, Beijing Municipality 101199, China
Chongqing, Chongqing Municipality 404000, China
Xiamen, Fujian 361003, China
Dongguan, Guangdong 523059, China
Guangzhou, Guangdong 510515, China
Guangzhou, Guangdong 510655, China
Nanjing, Jiangsu 210008, China
Xi'an, Shaanxi 710038, China
Taian, Shandong 271000, China
Shanghai, Shanghai Municipality 200025, China
Shanghai, Shanghai Municipality, China
Ürümqi, Xinjiang 830054, China
Hangzhou, Zhejiang 310000, China
Bogota, Cundinamarca 110111, Colombia
Prague, Praha 4 140 21, Czechia
Santo Domingo, Nacional 10104, Dominican Republic
Nice, Alpes-Maritimes 06202, France
Pessac, Aquitaine 33600, France
Marseille, Bouches-du-Rhone 13915, France
Reims, Champagne-Ardenne 51092, France
Neuilly-sur-Seine, Hauts-de-Seine 92200, France
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Nantes, Pays de la Loire Region 44093, France
Le Kremlin-Bicêtre, Val-de-Marne 94270, France
Tbilisi, Adjara 0186, Georgia
Munich, Bavaria 81337, Germany
Duisburg, North Rhine-Westphalia 47055, Germany
Minden, North Rhine-Westphalia 32423, Germany
Münster, North Rhine-Westphalia 48155, Germany
Ludwighafen Am Rhein, Rhineland-Palatinate 67067, Germany
Kiel, Schleswig-Holstein 24105, Germany
Athens, Attica 115 27, Greece
Nikaia Piraeus, Attica 184 54, Greece
Thessaloniki, Central Macedonia 54642, Greece
Heraklion, Crete 711 10, Greece
Békéscsaba, Bekescsaba 5600, Hungary
Eger, Heves County 3300, Hungary
Tatabánya, Komárom-Esztergom 2800, Hungary
Monserrato, Cagliari 09042, Italy
Milan, Lombardy 20122, Italy
Rho, Milano 20017, Italy
Palermo, Sicily 90146, Italy
Padova, Veneto 35128, Italy
Bologna, 40138, Italy
Milan, 20132, Italy
Fukuyama, Hiroshima 720-0825, Japan
Shimizu, Shizuoka 411-8611, Japan
Bunkyō, Tokyo 113-8519, Japan
Minato-ku, Tokyo 105-8470, Japan
Minato-ku, Tokyo 108-8642, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Shinagawa-ku, Tokyo 141-0022, Japan
Riga, LV1002, Latvia
Kaunas, Kaunas County 50161, Lithuania
Ampang, Selangor 68000, Malaysia
Tlajumulco de Zuniga, Jalisco 45640, Mexico
Mexico City, Mexico City 14050, Mexico
Monterrey, Nuevo León 64460, Mexico
Mérida, Yucatán 97130, Mexico
Tilburg, North Brabant 5022 GC, Netherlands
Amsterdam, North Holland 1081 HZ, Netherlands
Rotterdam, South Holland 3045 PM, Netherlands
Lørenskog, Akershus 1478, Norway
Poznan, Greater Poland Voivodeship 60-324, Poland
Krakow, Lesser Poland Voivodeship 31-506, Poland
Wroclaw, Lower Silesian Voivodeship 54-239, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Lisbon, Lisbon District 1349-019, Portugal
Lisbon, 1649-035, Portugal
Bucharest, Bucharest 022328, Romania
Cluj-Napoca, Cluj 400006, Romania
Târgu Mureş, Mureș County 540205, Romania
Timișoara, Timiș County 300002, Romania
Belgrade, Beograd 11000, Serbia
Belgrade, Beograd 11080, Serbia
Singapore, Central Singapore 308433, Singapore
Slovakia, Banská Bystrica Region 974 01, Slovakia
Wŏnju, Kang-won-do 26426, South Korea
Suwon, Kyonggi-do 16247, South Korea
Haeundae-gu, Pusan-Kwangyokshi 48108, South Korea
Dongjak-gu, Seoul 06973, South Korea
Daejeon, Taejon-Kwangyokshi 34943, South Korea
Seoul, 03312, South Korea
Seoul, 03722, South Korea
Galdakao-Usansolo, Bizkaia 48960, Spain
Valencia, Valencia 46026, Spain
Madrid, 28046, Spain
Bern, Canton of Bern 3012, Switzerland
Sankt Gallen, Canton of St. Gallen 9000, Switzerland
Zurich, Canton of Zurich 8091, Switzerland
Changhua County, Changhua 50006, Taiwan
Istanbul- Fatih, Istanbul 34098, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008, Ukraine
Kyiv, Kyivska Oblast 04210, Ukraine
Lviv, Lviv Oblast 79010, Ukraine
Vinnytsia, Vinnytsia Oblast 21009, Ukraine
Vinnytsia, Vinnytsia Oblast 21018, Ukraine
Vinnytsia, Vinnytsia Oblast 21029, Ukraine
Lutsk, Volyn Oblast 43005, Ukraine
Kyiv, 03057, Ukraine
London, England E11 1NR, United Kingdom
Southampton, Hampshire SO16 0YD, United Kingdom
London, London, City of NW1 2PG, United Kingdom
West Midlands, Walsall WS2 9PS, United Kingdom