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VTX958 for Psoriatic Arthritis

Phase 2
Waitlist Available
Research Sponsored by Ventyx Biosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Study Summary

This trial will assess if a drug, VTX958, is safe & effective in adults with Psoriatic Arthritis. 195 people will take VTX958 or placebo for 16 weeks. Follow up 30 days later.

Who is the study for?
Adults with active Psoriatic Arthritis, a history of plaque psoriasis or nail changes due to psoriasis, and diagnosed for at least 6 months can join. Women must use effective contraception if of childbearing potential. Men should agree to use condoms if their partner can bear children. Excluded are those with inflammatory bowel disease, uveitis, hepatitis B/C, HIV/AIDS, TB, immune deficiencies or non-plaque psoriasis.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of two doses (A & B) of VTX958 compared to a placebo in treating Psoriatic Arthritis over 16 weeks followed by a long-term extension phase of 36 weeks. Participants will be randomly assigned to receive either the drug or placebo.See study design
What are the potential side effects?
While specific side effects for VTX958 aren't listed here, common side effects for arthritis medications may include gastrointestinal issues like nausea or diarrhea; liver problems; skin reactions; increased risk of infections; and allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Secondary outcome measures
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: VTX958 Dose BExperimental Treatment1 Intervention
Group II: VTX958 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Ventyx Biosciences, IncLead Sponsor
2 Previous Clinical Trials
354 Total Patients Enrolled
Matt Cascino, MDStudy DirectorVentyx Biosciences, Inc
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715125 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target demographic for this research confined to individuals aged 25 and above?

"This medical trial is available to individuals aged 18 and up, but not exceeding 75 years."

Answered by AI

What measures have been taken to mitigate the risks of VTX958 Dose A?

"Based on the available evidence, VTX-958 Dose A was concluded to have an estimated safety rating of 2. This is due to this being a Phase 2 trial and thus lack of proof for efficacy but some data indicating its relative safety."

Answered by AI

Is the research team currently accepting participants for this investigation?

"Yes, the information hosted on clinicaltrials.gov suggests that this experiment is currently looking for participants to enroll. It was initially posted in January 31st 2023 and updated most recently on February 4th of the same year. The trial requires 195 patients between two sites to be enrolled."

Answered by AI

How many people are participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov shows us that this medical trial was posted on January 31st 2023 and has been updated recently on February 4th 2023, thus actively recruiting patients for enrollment at two separate sites with a total requirement of 195 participants."

Answered by AI

What is the primary intent of this medical experiment?

"This clinical trial, monitored over 16 weeks, aims to gauge the frequency of Treatment Emergent Adverse Events (TEAEs) from Week 0 until Week 16. Auxiliary objectives include: establishing the proportion of patients achieving 75% reduction in their Psoriasis Area and Severity Index (PASI75), measuring changes in Short Form Health Survey - 36 items' (SF-36's) physical component score (PCS) at Week 16, and assessing the number of participants reaching American College of Rheumatology criteria ACR50 by week sixteen."

Answered by AI

What criteria must potential participants meet to be eligible for this research initiative?

"This clinical trial is accepting 195 participants who are between 18 and 75 years old, diagnosed with psoriatic arthritis for at least 6 months, present active signs of plaque psoriasis or nail changes related to psoriasis, have 3 swollen joints and 3 tender joints upon screening as well as day one. Women must not be able to conceive or use highly effective contraception during the study and 30 days after the last dose while men in relationships with women capable of becoming pregnant must wear condoms throughout the duration of the experiment plus an additional 90 days following their final dose."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Site # 840015
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
2023. "VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05715125.
~95 spots leftby Apr 2025
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