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)
2期
已完成
NCT05013905
| 适应症 | Crohn Disease |
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| 分期 | 2期 |
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| 申办方 | Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
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| 状态 | 已完成 |
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| 受试者人数 | 55 人 |
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| 干预(药物) | Tulisokibart, Companion Diagnostic (CDx) |
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| 开始日期 | 2021年7月28日 |
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| 完成日期 | 2022年9月23日 |
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| 结果公布日 | 2023年11月1日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。