BENITIONSClinical Trial Intelligence

A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)

Фаза 2 Завершено NCT05013905

ЗаболеваниеCrohn Disease
ФазаФаза 2
СпонсорPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
СтатусЗавершено
Участники55 участн.
ВмешательствоTulisokibart, Companion Diagnostic (CDx)
Дата начала28.07.2021
Дата завершения23.09.2022
Публикация результатов1.11.2023

Кратко

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.

Adverse Events

Up to approximately 18 weeks · Participants

Induction Tulisokibart44 Participants

Serious Adverse Events

Up to approximately 18 weeks · Participants

Induction Tulisokibart9 Participants

Adverse Events Leading to Discontinuation

Up to approximately 12 weeks · Participants

Induction Tulisokibart2 Participants

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