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

Phase 1

• Conditions: Moderately to severely active Crohn’s disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-003365-38-PL
• Lead Sponsor: Ventyx Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 93

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy of VTX958 in achieving reduction in CDAI score at the end of the Induction Period;Secondary Objective: •Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response andremission at the end of the Induction Period<br>•Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remissionat the end of the Induction Period;Primary end point(s): •Change from baseline in mean Crohn’s disease activity index (CDAI) score at Week 12;Timepoint(s) of evaluation of this end point: at Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of participants achieving endoscopic response at Week 12<br>•Change from baseline in mean simple endoscopic score in Crohn’s disease (SES-CD) at Week 12<br>•Proportion of participants achieving clinical remission at Week 12<br>•Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12<br>•Proportion of participants achieving clinical response at Week 12<br>•Proportion of participants achieving endoscopic response and clinical remission (in the same participant) at Week 12;Timepoint(s) of evaluation of this end point: at Week 12