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
| Заболевание | Crohn Disease |
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| Фаза | Фаза 2 |
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| Спонсор | Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
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| Статус | Завершено |
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| Участники | 55 участн. |
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| Вмешательство | Tulisokibart, Companion Diagnostic (CDx) |
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| Дата начала | 28.07.2021 |
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| Дата завершения | 23.09.2022 |
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| Публикация результатов | 1.11.2023 |
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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 Tulisokibart | 44 Participants |
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Serious Adverse Events
Up to approximately 18 weeks · Participants
| Induction Tulisokibart | 9 Participants |
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Adverse Events Leading to Discontinuation
Up to approximately 12 weeks · Participants
| Induction Tulisokibart | 2 Participants |
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