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Набира участници Фаза 2 NCT06850727

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Ulcerative Colitis (UC) UC - Ulcerative Colitis

Спонсор: Odyssey Therapeutics

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.
Кой може да участва
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a confirmed diagnosis of ulcerative colitis (UC) * Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score * Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of Crohn's disease or indeterminate colitis * Has had extensive colonic resection * Has colostomy or ileostomy * Has uncontrolled primary sclerosing cholangitis
Места на провеждане 9
Австралия (1)
Sunshine Coast University
Birtinya
Канада (1)
CHUM
Montreal
Чехия (1)
CHUM - Pavillon R
Polička
Jordan (1)
Jordan University Hospital
Amman
Lithuania (1)
The Hospital of Lithuanian University of Health Sciences
Kaunas
Moldova (1)
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau
New Zealand (1)
PCRN Auckland
Auckland
Полша (1)
Centrum Medyczne
Bydgoszcz
Ukraine (1)
Regional Clinical Hospital
Ivano-Frankivsk
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
02.06.2025
Крайна дата
01.11.2026
Регистрационен номер
NCT06850727
Източник
anzctr
Запитване за медицински туризъм

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