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VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease — Harmony-CD  

Crohn Disease Clinical Trial

Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderately to Severely Active Crohn's Disease

Clinical Trial Summary

This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.

Clinical Trial Description

This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease. Approximately 132 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no). The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug. Objectives Primary Objectives * Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score and endoscopic response at the end of the Induction Period Secondary Objectives - Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period - Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05688852
Study type Interventional
Source Ventyx Biosciences, Inc
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 22, 2022
Completion date May 2027
View Details
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