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