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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 CD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ventyx Biosciences, Inc

Criteria

Inclusion Criteria:

1. Men or women, 18 to 75 years of age, inclusive, at the time of consent

2. Capable of giving signed informed consent

3. Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.

4. Moderately to severely active CD

Exclusion Criteria:

1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis

2. Presence of a stoma or ileoanal pouch

3. Presence of currently known complications of CD such as fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization

4. Known diagnosis of short gut or bowel syndrome

5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study