Crohn's Disease Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. The primary hypotheses for Study 1 and Study 2 are that tulisokibart is superior to placebo in achieving the coprimary outcome measures of clinical remission by either Crohn's Disease Activity Index (CDAI, primary endpoint recommended by United States Food and Drug Administration [US/FDA]) or stool frequency and abdominal pain score (primary endpoint recommended by European Union European Medicines Agency [EU/EMA]) and endoscopic response.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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Phase 3 | |
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Phase 1 | |
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Phase 3 | |
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| Recruiting |
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| Recruiting |
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Phase 1 | |
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N/A | |
| Terminated |
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N/A | |
| Not yet recruiting |
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N/A | |
| Terminated |
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Phase 2 | |
| Completed |
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Phase 1 | |
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| Active, not recruiting |
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N/A | |
| Completed |
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||
| Completed |
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Phase 1 | |
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N/A | |
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Phase 3 |