NCT05688852

VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Ventyx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 93 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 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

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	VTX958	Dose A VTX958
DRUG	VTX958	Dose B VTX958
DRUG	VTX958 Placebo	Placebo

Timeline

• Start date: 2023-01-25
• Primary completion: 2024-06-27
• Completion: 2024-12-20
• First posted: 2023-01-18
• Last updated: 2025-07-03

Locations

105 sites across 15 countries: United States, Australia, Brazil, Bulgaria, Canada, Czechia, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Moldova, Poland, Slovakia

Regulatory

• FDA-regulated drug study