RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease

Autoimmune Disorder
Crohn's Disease

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Study 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

Gender

All

Age

≥18 Years & ≤ 75 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease

For the latest version of this information please go to www.forpatients.roche.com