A Phase 2 interventional study of Dose A VTX958 and Dose B VTX958 in Psoriatic Arthritis, sponsored by Ventyx Biosciences, Inc. Terminated at 46 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Ventyx Biosciences, Inc · Phase 2, Interventional, and Treatment
The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 205 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis 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: Placebo
Drug: Dose A VTX958
Drug: Dose B VTX958
Dose A VTX958
Dose B VTX958
Placebo
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Time frame: Week 16
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
Time frame: Week 16
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
HAQ-DI assesses functional ability. It is a 20 question instrument that assesses the degree of difficulty with accomplishing tasks in 8 functional areas (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The overall HAQ-DI score is the mean of the 8 functional area scores and ranges from 0 to 3. Lower scores are indicative of improved functional ability.
Time frame: Week 16
Proportion of participants achieving 75% reduction in the Psoriasis Area and Severity Index (PASI75) score at Week 16, in participants with at least 3% body surface area (BSA) involvement at baseline
PASI is used to assess the severity of psoriasis and response to therapy. Each body region is evaluated separately for body surface area percentage of involvement and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement) and for erythema, induration, and scaling, each is rated on scale of 0 to 4 (from none to maximum severity). PASI numeric scores range from 0 (no psoriasis) to 72 (maximal disease). Higher scores indicate more severe disease.
Time frame: Week 16
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
SF-36 is a 36-item, patient-reported measure of health status and quality of life, which includes 8 domains (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). Each of the 8 domains contribute in different proportions to the physical component summary (PCS) score and the mental component summary (MCS) score, which are normalized to general US population norms and range from 0 to 100 (where higher scores correspond to a better quality of life).
Time frame: Week 16
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort
Time frame: Week 16
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort
Time frame: Week 16
Plan to share: Undecided
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This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ventyx Biosciences, Inc