VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
Megadott ok: Sponsor Decision
Key facts
- Where
- Békéscsaba, Budapest, Gyöngyös, Szeged, Szekszárd és Tatabánya, MagyarországSee the 6 sites
- Phase
- 2. fázis
Where in Magyarország
- BékéscsabaBékéscsaba, MagyarországNo longer taking part
- BudapestBudapest, MagyarországNo longer taking part
- GyöngyösGyöngyös, MagyarországNo longer taking part
- SzegedSzeged, MagyarországNo longer taking part
- SzekszárdSzekszárd, MagyarországNo longer taking part
- TatabányaTatabánya, MagyarországNo longer taking part
Trial details
- Who runs it
- Ventyx Biosciences, Inc
- Trial code
- NCT05688852
- Record updated
- 2025. július 3.
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: Men or women, 18 to 75 years of age, inclusive, at the time of consent; Capable of giving signed informed consent; Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence; Moderately to severely active CD.
Exclusion: Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization; Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study; Known diagnosis of short gut or bowel syndrome; Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis; Presence of a stoma or ileoanal pouch.