A Phase 2 interventional study of VTX958 and VTX958 in Crohn Disease, sponsored by Ventyx Biosciences, Inc. Terminated at 105 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Ventyx Biosciences, Inc · Phase 2, Interventional, and Treatment
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.
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
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 107 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Ventyx Biosciences, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: VTX958
Drug: VTX958
Drug: VTX958 Placebo
Dose A VTX958
Dose B VTX958
Placebo
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
Change in Mean CDAI (Crohn's disease Activity Index). CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
Time frame: During screening to week 12
The proportion of participants achieving endoscopic response at Week 12
SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
Time frame: During screening to week 12
Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12
Change from baseline in mean simple endoscopic score in Crohn's disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
Time frame: During screening to week 12
Proportion of participants achieving clinical remission at Week 12
Clinical remission is defined as a CDAI score \< 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
Time frame: During screening to week 12
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 and unweighted CDAI component of daily average stool frequency (SF) score ≤ 3
Time frame: During screening to week 12
Proportion of participants achieving clinical response at Week 12
Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score \< 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
Time frame: During screening to week 12
Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12
Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.
Time frame: During screening to week 12
Showing the first 100 of 105 sites across 15 countries.
Plan to share: Undecided
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This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ventyx Biosciences, Inc