A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Фаза 2 Завершено NCT05499130

Кратко

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures * To evaluate the safety and tolerability of 2 different doses of TEV-48574 * To evaluate the immunogenicity of 2 different dioses of TEV-48574 The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS

Week 14 · Participants

Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD

Baseline to Week 14 · Participants

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• A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
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• A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
• A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
• Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Все исследования