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

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

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: VTX958; Drug: VTX958; Drug: VTX958; Drug: VTX958

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Fredericton, Canada
    • Local Site # 124012
  • Mississauga, Canada
    • Local Site # 124010
  • Montréal, Canada
    • Local Site # 124002
  • North Bay, Canada
    • Local Site # 124004
  • Oshawa, Canada
    • Local Site # 124011
  • Peterborough, Canada
    • Local Site # 124007
  • Québec City, Canada
    • Local Site # 124008
  • Toronto, Canada
    • Local Site # 124005
  • Windsor, Canada
    • Local Site # 124006
• Poland
  • Białystok, Poland
    • Local Site # 616015
  • Białystok, Poland
    • Local Site # 616016
  • Katowice, Poland
    • Local Site # 616001
  • Kraków, Poland
    • Local Site # 616014
  • Lublin, Poland
    • Local Site #616010
  • Mikołów, Poland
    • Local Site # 616011
  • Nowa Sól, Poland
    • Local Site # 616009
  • Ostrowiec Świętokrzyski, Poland
    • Local Site # 616003
  • Poznań, Poland
    • Local Site # 616008
  • Szczecin, Poland
    • Local Site # 616007
  • Szczecin, Poland
    • Local Site # 616013
  • Warszawa, Poland
    • Local Site # 616005
  • Wrocław, Poland
    • Local Site # 616002
  • Wrocław, Poland
    • Local Site # 616006
  • Wrocław, Poland
    • Local Site # 616018
  • Łódź, Poland
    • Local Site # 616004
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Local Site # 840012
    • Birmingham, Alabama, United States, 35244
      • Local Site # 840006
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Local Site # 840028
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Local Site # 840032
    • North Little Rock, Arkansas, United States, 72117
      • Local Site # 840041
  • California
    • Fountain Valley, California, United States, 92708
      • Local Site # 840031
    • Lomita, California, United States, 90717
      • Local Site # 840026
    • Santa Rosa, California, United States, 95405
      • Local Site # 840019
    • Sherman Oaks, California, United States, 91403
      • Local Site # 840003
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Local Site # 840040
    • Doral, Florida, United States, 33122
      • Local Site # 840011
    • Hialeah, Florida, United States, 33012
      • Local Site # 840023
    • Miami Lakes, Florida, United States, 33104
      • Local Site # 840021
    • North Miami Beach, Florida, United States, 33162
      • Local Site # 840044
    • Ocala, Florida, United States, 34470
      • Local Site # 840010
    • Tampa, Florida, United States, 33607
      • Local Site # 840004
    • Tampa, Florida, United States, 33613
      • Local Site # 840001
    • West Palm Beach, Florida, United States, 33406
      • Local Site # 840045
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Local Site # 840029
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Local Site # 840035
    • Indianapolis, Indiana, United States, 46250
      • Local Site # 840005
    • Plainfield, Indiana, United States, 46168
      • Local Site # 840030
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Local Site # 840013
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Local Site # 840022
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Local Site # 840008
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Local Site # 840016
    • Fort Gratiot, Michigan, United States, 48059
      • Local Site # 840007
    • Troy, Michigan, United States, 48084
      • Local Site # 840002
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Local Site # 840034
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Local Site # 840024
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Local Site # 840027
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Local Site # 840042
  • Ohio
    • Mason, Ohio, United States, 45040
      • Local Site # 840037
  • Oregon
    • Portland, Oregon, United States, 97223
      • Local Site # 840009
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Local Site # 840038
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Local Site # 840015
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Local Site # 840039
  • Washington
    • Spokane, Washington, United States, 99202
      • Local Site # 840014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: VTX958 Dose A	Drug: VTX958; Dose A; Drug: VTX958; Dose B; Drug: VTX958; Dose C; Drug: VTX958; Dose D
Experimental: VTX958 Dose B	Drug: VTX958; Dose A; Drug: VTX958; Dose B; Drug: VTX958; Dose C; Drug: VTX958; Dose D
Experimental: VTX958 Dose C	Drug: VTX958; Dose A; Drug: VTX958; Dose B; Drug: VTX958; Dose C; Drug: VTX958; Dose D
Experimental: VTX958 Dose D	Drug: VTX958; Dose A; Drug: VTX958; Dose B; Drug: VTX958; Dose C; Drug: VTX958; Dose D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks	Proportion of subjects achieving PASI-75 at Week 16	Day 1 of Placebo-controlled treatment period to week 16
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion	Incidence of AEs and SAEs	Screening through study completion, up to 76 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks	Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16	Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks	Change and percent change from baseline in PASI at Week 16	Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks	Proportion of participants achieving PASI-90 at Week 16	Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks	Proportion of participants achieving PASI-100 at Week 16	Day 1 of Placebo-controlled treatment period to week 16
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks	Change from baseline in DLQI scores at Week 16	Day 1 of Placebo-controlled treatment period to week 16
Body Surface Area (BSA) Efficacy at 16 weeks	Change from baseline in BSA at Week 16	Day 1 of Placebo-controlled treatment period to week 16

Collaborators and Investigators

• Sponsor: Ventyx Biosciences, Inc
• Investigators: Study Director: Snehal Naik, PhD, Ventyx Biosciences, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: TYK2 inhibitor; moderate to severe psoriasis; Ventyx; VTX958
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: VTX958-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No