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Активно (без набиране) Фаза 2 NCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Colitis, Ulcerative

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
Кой може да участва
Inclusion Criteria: * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline * Moderately to severely active UC as assessed by the modified Mayo score * Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity * If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: * Has severe extensive colitis as defined in the protocol * Extent of inflammatory disease limited to the rectum * Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD) * Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer * Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Места на провеждане 32
Argentina (1)
CIPREC
Buenos Aires
Австралия (1)
Box Hill Hospital
Box Hill
Белгия (1)
Imelda Ziekenhuis
Bonheiden
Бразилия (1)
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
България (1)
Medical Centre Hipocrat
Haskovo
Канада (1)
Foothills Hospital
Calgary , Alberta
Chile (1)
Hospital Clinico Regional Dr. Guillermo Grant Benavente
Concepción
Китай (1)
China Japan Friendship Hospital
Chaoyang
Хърватия (1)
Opca bolnica Bjelovar
Bjelovar
Чехия (1)
Vojenska nemocnice Brno
Brno
Дания (1)
Aalborg Hospital
Aalborg
Estonia (1)
East Tallinn Central Hospital
Tallinn
Франция (1)
CHU Amiens - Hopital Sud
Amiens
Гърция (1)
Sotiria General State Hospital of Chest Diseases
Athens
Унгария (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Индия (1)
M S Ramaiah Medical College and Hospital
Bangalore
Израел (1)
Haemek Medical Center - Afula
Afula
Италия (1)
Università degli Studi di Bari
Bari
Япония (1)
Asahikawa Medical University Hospital
Asahikawa
Jordan (1)
Istishari Hospital
Amman
Нидерландия (1)
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam
New Zealand (1)
Christchurch Hospital
Christchurch
Норвегия (1)
Alesund sjukehus
Ålesund
Полша (1)
Szpital Uniwersytecki No2
Bydgoszcz
Словакия (1)
FNsP F.D.R. Banska Bystrica
Banská Bystrica
South Africa (1)
Worthwhile Clinical Trials Lakeview Hospital
Benoni
Южна Корея (1)
Inje University Haeundae Paik Hospital
Busan
Испания (1)
Hosp Clinic de Barcelona
Barcelona
Швеция (1)
Karolinska Universitetssjukhuset Solna
Solna
Taiwan (1)
Changhua Christian Hospital
Changhua
Великобритания (1)
Royal Victoria Hospital
Belfast
САЩ (1)
Valley Gastroenterology Medical Group
Arcadia , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
19.09.2022
Крайна дата
27.03.2029
Регистрационен номер
NCT05242484
Източник
anzctr
Запитване за медицински туризъм

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