The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    Ventyx
Previous Study | Return to List | Next Study

VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (Serenity PsO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05655299
Recruitment Status : Terminated (Business Decision)
First Posted : December 19, 2022
Last Update Posted : December 28, 2023
Sponsor:
Information provided by (Responsible Party):
Ventyx Biosciences, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This is a study to understand if taking VTX958 is safe and effective in participants diagnosed with moderate to severe psoriasis (PsO). Approximately 200 patients will take VTX958 Dose A, VTX958 Dose B, VTX958 Dose C, VTX958 Dose D, or placebo.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 16-week double-blind period (a participant receives active Dose A, Dose B, Dose C, Dose D, or placebo), a 16-week Long Term Extension (LTE) period, a 36-week Open Label Extension (OLE) period and a 4-week Follow-Up Period. The maximal duration of treatment will be 17 months.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: VTX958 Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will employ a double-blind design. Subjects, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the Treatment Period from the time of randomization until the database lock for the study.
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderate to Severe Psoriasis
Actual Study Start Date : November 17, 2022
Actual Primary Completion Date : September 13, 2023
Actual Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: VTX958 Dose A Drug: VTX958
Dose A
Experimental: VTX958 Dose B Drug: VTX958
Dose B
Experimental: VTX958 Dose C Drug: VTX958
Dose C
Experimental: VTX958 Dose D Drug: VTX958
Dose D
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Proportion of subjects achieving PASI-75 at Week 16

  2. Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion [ Time Frame: Screening through study completion, up to 76 weeks ]
    Incidence of AEs and SAEs


Secondary Outcome Measures :
  1. Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16

  2. PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Change and percent change from baseline in PASI at Week 16

  3. PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Proportion of participants achieving PASI-90 at Week 16

  4. PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Proportion of participants achieving PASI-100 at Week 16

  5. Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Change from baseline in DLQI scores at Week 16

  6. Body Surface Area (BSA) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
    Change from baseline in BSA at Week 16


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participant aged 18 years or older.
  • 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.
  • Has moderate to severe plaque psoriasis as defined by a PASI score of ≥ 12 and an sPGA score of ≥ 3 at screening and Day 1.
  • Has plaque psoriasis covering ≥ 10% of the total BSA at screening and Day 1.
  • Deemed by the investigator to be eligible for phototherapy or systemic therapy.
  • Females of childbearing potential must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last dose of study product.

Exclusion Criteria:

  • Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study.
  • Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis.
  • History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Participant is known to have immune deficiency or is immunocompromised.
  • Has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, active uveitis, inflammatory bowel disease, that currently require systemic treatment (including corticosteroids, immunosuppressants, or biologics).

Note: Participants with immune-mediated conditions commonly associated with psoriasis that do not require systemic treatment may be included in the study.

  • Has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], Janus kinase [JAK] inhibitors, or tar) within 2 weeks prior to Day 1.
  • Has used any systemic treatment that could affect psoriasis (including corticosteroids, oral retinoids, immunosuppressive medication, anakinra, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1.

Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.

  • Participant has received any ultraviolet B (UVB) phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
  • Participant has had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to Day 1.
  • Participant has received treatment with an investigational or marketed TYK2 inhibitor.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05655299


Locations
Show Show 63 study locations
Sponsors and Collaborators
Ventyx Biosciences, Inc
Investigators
Layout table for investigator information
Study Director: Snehal Naik, PhD Ventyx Biosciences, Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ventyx Biosciences, Inc
ClinicalTrials.gov Identifier: NCT05655299    
Other Study ID Numbers: VTX958-201
First Posted: December 19, 2022    Key Record Dates
Last Update Posted: December 28, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ventyx Biosciences, Inc:
TYK2 inhibitor
moderate to severe psoriasis
Ventyx
VTX958
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases