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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT05688852

Run by

Ventyx Biosciences, Inc

People needed

107

Starts

2023-01-25

Expected to finish

2024-12-20

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
• Presence of a stoma or ileoanal pouch
• 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
• Known diagnosis of short gut or bowel syndrome
• Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study

Where it is running

• Local Site #348104 — Szeged, Hungary
• Local Site # 348103 — Szekszárd, Hungary
• Local Site # 348105 — Tatabánya, Hungary
• Local Site # 376103 — Ashkelon, Israel
• Local Site # 376108 — Haifa, Israel
• Local Site # 376105 — Jerusalem, Israel
• Local Site # 376107 — Jerusalem, Israel
• Local Site # 376101 — Petah Tikva, Israel
• Local Site # 376102 — Rehovot, Israel
• Local Site # 380104 — Milan, Lombardy, Italy
• Local Site # 380105 — Negrar, Verona, Italy
• Local Site # 380101 — Bari, Italy
• Local Site # 380107 — Milan, Italy
• Local Site # 380109 — Rome, Italy
• Local Site # 380106 — Turin, Italy
• Local Site # 440101 — Vilnius, Lithuania
• Local Site # 498101 — Chisinau, Moldova
• Local Site # 498102 — Chisinau, Moldova
• Local Site # 616116 — Bydgoszcz, Poland
• Local Site #616113 — Knurów, Poland
• Local Site # 616112 — Krakow, Poland
• Local Site # 616110 — Lodz, Poland
• Local Site # 616105 — Lodz, Poland
• Local Site # 616101 — Lodz, Poland
• Local Site # 348106 — Gyöngyös, Hungary

Full record on ClinicalTrials.gov

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