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VTX958 for Moderate to Severe Psoriasis (Serenity PsO Trial)

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
History of primarily plaque psoriasis for at least 6 months prior to the screening visit
Has had stable psoriasis conditions for at least 3 months before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of placebo-controlled treatment period to week 16
Awards & highlights

Serenity PsO Trial Summary

This trial will test if a daily oral drug is safe and effective for treating moderate-severe psoriasis. 200 people will take the drug, or a placebo, for 4 months.

Who is the study for?
Adults with a history of plaque psoriasis for at least 6 months, having moderate to severe symptoms. Participants must have stable psoriasis and meet specific severity scores on PASI and sPGA scales. They should be candidates for phototherapy or systemic therapy and not planning pregnancy during the study.Check my eligibility
What is being tested?
The trial is testing VTX958's safety and effectiveness in different doses compared to a placebo over several periods totaling up to 17 months, including double-blind, long-term extension (LTE), open-label extension (OLE), and follow-up.See study design
What are the potential side effects?
While the side effects are not specified here, common side effects for psoriasis treatments may include skin irritation, headaches, fatigue, nausea, or potential allergic reactions.

Serenity PsO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have had plaque psoriasis for at least 6 months before the screening visit.
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Your psoriasis has been the same for at least 3 months before screening.

Serenity PsO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of placebo-controlled treatment period to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of placebo-controlled treatment period to 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
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
Secondary outcome measures
Body Surface Area (BSA) Efficacy at 16 weeks
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
PASI Efficacy at 16 weeks
+1 more

Serenity PsO Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: VTX958 Dose DExperimental Treatment1 Intervention
Group II: VTX958 Dose CExperimental Treatment1 Intervention
Group III: VTX958 Dose BExperimental Treatment1 Intervention
Group IV: VTX958 Dose AExperimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Ventyx Biosciences, IncLead Sponsor
2 Previous Clinical Trials
337 Total Patients Enrolled
Snehal Naik, PhDStudy DirectorVentyx Biosciences, Inc

Media Library

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05655299 — Phase 2
Psoriasis Research Study Groups: VTX958 Dose A, VTX958 Dose B, VTX958 Dose C, VTX958 Dose D, Placebo
Psoriasis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05655299 — Phase 2
Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655299 — Phase 2

Frequently Asked Questions

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

Has the dosage of VTX958 D been officially sanctioned by the Food and Drug Administration?

"As VTX958 Dose D is currently in a Phase 2 trial, the safety of this medication has been judged to be at level 2 due to some evidence from clinical tests but no data indicating its efficacy."

Answered by AI

What is the extent of this research project's presence in urban areas?

"Presently, recruitment is taking place at 5 distinct sites. These centres are found in Portland, Indianapolis and Hot Springs as well as two other locations. It's recommended that prospective patients select the nearest medical centre to reduce their need to travel if they decide to join this trial."

Answered by AI

Does this experiment have any available openings for participants?

"Affirmative. Clinicaltrials.gov has evidence that this medical experimentation is actively enrolling participants and was published on November 17th 2022, with the most current update made on December 8 of the same year. 200 subjects are needed from 5 distinct locations for this research project."

Answered by AI

How many individuals are participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial has been open since November 17th 2022 and was last modified on December 8th of the same year; seeking 200 participants from 5 different healthcare facilities."

Answered by AI

What objectives are researchers hoping to attain from this medical experiment?

"This clinical trial will measure its primary outcome, Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks, over a 24 week period. Secondary outcomes include PASI-100 Proportion Achievement at Week 16 , alteration in Body Surface Area (BSA) from baseline by the end of Week 16, and change in Dermatology Life Quality Index (DLQI) scores from pre-trial measurement to completion of the study's sixteenth week."

Answered by AI
~95 spots leftby Mar 2025