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RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease
Autoimmune Disorder Crohn's Disease
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Trial Identifier
NCT05910528, GA45392, 2023-504265-23-00
Condition
Crohns Disease
Official Title
A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
Study Summary
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.
Eligibility Criteria
All
≥18 Years & ≤ 75 Years
No
Inclusion Criteria
- Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- Elevated very soft or liquid stool frequency and/or abdominal pain
- Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
Exclusion Criteria
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com