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Активно (без набиране) Фаза 2 NCT06290934

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

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

Спонсор: Gilead Sciences

Налично на: БГ
Обобщение
The goal of this study is to learn if emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo. The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.
Кой може да участва
Key Inclusion Criteria: * Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents. * Individuals have UC with minimum disease extent of 15 cm from the anal verge. * Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2. * Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy. * Individuals have an inadequate response or loss of response or are intolerant to \< 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action) Key Exclusion Criteria: * Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis. * Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization. * Have any history of exposure to vedolizumab or other integrin antagonists * Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply
Места на провеждане 21
Австралия (1)
Macquarie University
Sydney , New South Wales
Белгия (1)
Imeldaziekenhuis
Bonheiden
Канада (1)
TDDA Specialty Reserach
Vaughan
Чехия (1)
PreventaMed, s.r.o.
Olomouc
Франция (1)
Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D
La Tronche
Georgia (1)
ARENSIA Exploratory Medicine
Tbilisi
Германия (1)
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik |
Dresden
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Унгария (1)
Békés Varmegye Kozponti Korhaz, dr Rethy Pal 4. Belgyégyaszat - Gasztroenterologia
Békéscsaba
Италия (1)
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Bologna
Malaysia (1)
Hospital Sultanah Aminah
Johor Bahru
Moldova (1)
PMSI Clinical Republican Hospital "Timofei Molneaga"
Chisinau
New Zealand (1)
Pacific Clinical Research Network - Auckland
Auckland
Полша (1)
Centrum Medyczne "Medis"
Bydgoszcz
Румъния (1)
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Bucharest
Сърбия (1)
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department
Belgrade
Южна Корея (1)
Inje University Haeundae Paik Hospital IRB
Busan
Испания (1)
Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol
Ferrol
Taiwan (1)
Changhua Christian Hospital
Changhua
Великобритания (1)
Southmead Hospital - North Bristol Trust Clinical Research Centre
Bristol
САЩ (1)
Onyx Clinical Research (Clinic Location)
Peoria , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
27.03.2024
Крайна дата
01.04.2028
Регистрационен номер
NCT06290934
Източник
anzctr
Запитване за медицински туризъм

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