A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Phase 3 – large-scale trial before approval
Conditions:
Ulcerative Colitis
Sponsor: Merck Sharp & Dohme LLC
trial.available_in:
БГ
Overview
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.
Description
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.
Who can participate
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
Locations
42
Argentina (1)
Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
Mar del Plata , Buenos Aires
Australia (1)
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
Kingswood , New South Wales
Belgium (1)
UZ Gent ( Site 0300)
Ghent , Oost-Vlaanderen
Brazil (1)
L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
Brasília , Federal District
Bulgaria (1)
MC Velingrad 2017 EOOD ( Site 0406)
Velingrad , Pazardzhik
Canada (1)
Heritage Medical Research Clinic ( Site 0004)
Calgary , Alberta
Chile (1)
Clinical Research Chile SpA ( Site 2201)
Valdivia , Los Ríos Region
China (1)
The First Affiliated Hospital of Anhui Medical University ( Site 3957)
Hefei , Anhui
Colombia (1)
Clínica las Américas ( Site 2318)
Medellín , Antioquia
Croatia (1)
Klinička bolnica Merkur ( Site 0505)
Zagreb , City of Zagreb
Czech Republic (1)
Vojenská Nemocnice Brno-Internal department ( Site 0605)
Brno , Brno-mesto
Dominican Republic (1)
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)
Santo Domingo , Nacional
Finland (1)
Tampereen yliopistollinen sairaala ( Site 4300)
Tampere , Pirkanmaa
France (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)
Nice , Alpes-Maritimes
Georgia (1)
LTD High Technology Hospital Medcenter ( Site 0802)
Batumi , Adjara
Germany (1)
Universitaetsklinikum Ulm. ( Site 0902)
Ulm , Baden-Wurttemberg
Greece (1)
Evangelismos General Hospital of Athens ( Site 4001)
Athens , Attica
Hungary (1)
Mohácsi Kórház ( Site 1008)
Mohács , Baranya
Israel (1)
Emek Medical Center ( Site 1106)
Afula
Italy (1)
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)
Monserrato , Cagliari
Japan (1)
Aichi Medical University Hospital ( Site 2841)
Nagakute , Aichi-ken
Latvia (1)
Liepaja Regional Hospital ( Site 4501)
Liepāja
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)
Kaunas , Kaunas County
Malaysia (1)
Hospital Sultanah Aminah ( Site 4702)
Johor Bahru , Johor
Mexico (1)
Morales Vargas Centro de Investigacion ( Site 2411)
León , Guanajuato
Netherlands (1)
Radboudumc ( Site 1402)
Nijmegen , Gelderland
New Zealand (1)
Waikato Hospital ( Site 2903)
Hamilton , Waikato Region
Norway (1)
Akershus Universitetssykehus ( Site 4200)
Lørenskog , Akershus
Poland (1)
Pratia Poznan ( Site 1530)
Poznan , Greater Poland Voivodeship
Romania (1)
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)
Bucharest , Bucharest
Serbia (1)
Clinical Hospital Center Dragisa Misovic ( Site 1708)
Belgrade , Beograd
Singapore (1)
Singapore General Hospital ( Site 4801)
Singapore , Central Singapore
Slovakia (1)
Breznianske centrum gastroenterologie ( Site 1806)
Brezno , Banská Bystrica Region
South Africa (1)
Wits Clinical Research-Research ( Site 3208)
Johannesburg , Gauteng
South Korea (1)
Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)
Wŏnju , Kang-won-do
Spain (1)
Hospital Germans Trias i Pujol ( Site 3413)
Badalona , Barcelona
Sweden (1)
Danderyds Sjukhus ( Site 4401)
Danderyd , Stockholm County
Taiwan (1)
Changhua Christian Hospital ( Site 3104)
Changhua County , Changhua
Turkey (1)
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)
Istanbul- Fatih , Istanbul
Ukraine (1)
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115)