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

Primary Purpose

Psoriasis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VTX958
VTX958
VTX958
VTX958
Placebo
Sponsored by
Ventyx Biosciences, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring TYK2 inhibitor, moderate to severe psoriasis, Ventyx, VTX958

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Site # 840012
  • Local Site # 840006
  • Local Site # 840028
  • Local Site # 840032
  • Local Site # 840041
  • Local Site # 840031
  • Local Site # 840026
  • Local Site # 840019
  • Local Site # 840003
  • Local Site # 840040
  • Local Site # 840011
  • Local Site # 840023
  • Local Site # 840021
  • Local Site # 840044
  • Local Site # 840010
  • Local Site # 840004
  • Local Site # 840001
  • Local Site # 840045
  • Local Site # 840029
  • Local Site # 840035
  • Local Site # 840005
  • Local Site # 840030
  • Local Site # 840013
  • Local Site # 840022
  • Local Site # 840008
  • Local Site # 840016
  • Local Site # 840007
  • Local Site # 840002
  • Local Site # 840034
  • Local Site # 840024
  • Local Site # 840027
  • Local Site # 840042
  • Local Site # 840037
  • Local Site # 840009
  • Local Site # 840038
  • Local Site # 840015
  • Local Site # 840039
  • Local Site # 840014
  • Local Site # 124012
  • Local Site # 124010
  • Local Site # 124002
  • Local Site # 124004
  • Local Site # 124011
  • Local Site # 124007
  • Local Site # 124008
  • Local Site # 124005
  • Local Site # 124006
  • Local Site # 616015
  • Local Site # 616016
  • Local Site # 616001
  • Local Site # 616014
  • Local Site #616010
  • Local Site # 616011
  • Local Site # 616009
  • Local Site # 616003
  • Local Site # 616008
  • Local Site # 616007
  • Local Site # 616013
  • Local Site # 616005
  • Local Site # 616002
  • Local Site # 616006
  • Local Site # 616018
  • Local Site # 616004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

VTX958 Dose A

VTX958 Dose B

VTX958 Dose C

VTX958 Dose D

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
Proportion of subjects achieving PASI-75 at Week 16
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
Incidence of AEs and SAEs

Secondary Outcome Measures

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
PASI Efficacy at 16 weeks
Change and percent change from baseline in PASI at Week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-90 at Week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-100 at Week 16
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
Change from baseline in DLQI scores at Week 16
Body Surface Area (BSA) Efficacy at 16 weeks
Change from baseline in BSA at Week 16

Full Information

First Posted
December 2, 2022
Last Updated
October 18, 2023
Sponsor
Ventyx Biosciences, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05655299
Brief Title
VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
Acronym
Serenity PsO
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ventyx Biosciences, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
TYK2 inhibitor, moderate to severe psoriasis, Ventyx, VTX958

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VTX958 Dose A
Arm Type
Experimental
Arm Title
VTX958 Dose B
Arm Type
Experimental
Arm Title
VTX958 Dose C
Arm Type
Experimental
Arm Title
VTX958 Dose D
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VTX958
Intervention Description
Dose A
Intervention Type
Drug
Intervention Name(s)
VTX958
Intervention Description
Dose B
Intervention Type
Drug
Intervention Name(s)
VTX958
Intervention Description
Dose C
Intervention Type
Drug
Intervention Name(s)
VTX958
Intervention Description
Dose D
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
Description
Proportion of subjects achieving PASI-75 at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
Description
Incidence of AEs and SAEs
Time Frame
Screening through study completion, up to 76 weeks
Secondary Outcome Measure Information:
Title
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks
Description
Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
PASI Efficacy at 16 weeks
Description
Change and percent change from baseline in PASI at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
PASI Efficacy at 16 weeks
Description
Proportion of participants achieving PASI-90 at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
PASI Efficacy at 16 weeks
Description
Proportion of participants achieving PASI-100 at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
Description
Change from baseline in DLQI scores at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16
Title
Body Surface Area (BSA) Efficacy at 16 weeks
Description
Change from baseline in BSA at Week 16
Time Frame
Day 1 of Placebo-controlled treatment period to week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snehal Naik, PhD
Organizational Affiliation
Ventyx Biosciences, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Local Site # 840012
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Local Site # 840006
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Local Site # 840028
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Local Site # 840032
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Local Site # 840041
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Local Site # 840031
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Local Site # 840026
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Local Site # 840019
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Local Site # 840003
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Local Site # 840040
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Local Site # 840011
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Local Site # 840023
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Local Site # 840021
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33104
Country
United States
Facility Name
Local Site # 840044
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Local Site # 840010
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Local Site # 840004
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Local Site # 840001
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Local Site # 840045
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Local Site # 840029
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Site # 840035
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Local Site # 840005
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Local Site # 840030
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Local Site # 840013
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Local Site # 840022
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Local Site # 840008
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Local Site # 840016
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Local Site # 840007
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Local Site # 840002
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Local Site # 840034
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Local Site # 840024
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Local Site # 840027
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Local Site # 840042
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Local Site # 840037
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Local Site # 840009
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Local Site # 840038
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Local Site # 840015
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Local Site # 840039
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Local Site # 840014
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Local Site # 124012
City
Fredericton
Country
Canada
Facility Name
Local Site # 124010
City
Mississauga
Country
Canada
Facility Name
Local Site # 124002
City
Montréal
Country
Canada
Facility Name
Local Site # 124004
City
North Bay
Country
Canada
Facility Name
Local Site # 124011
City
Oshawa
Country
Canada
Facility Name
Local Site # 124007
City
Peterborough
Country
Canada
Facility Name
Local Site # 124008
City
Québec City
Country
Canada
Facility Name
Local Site # 124005
City
Toronto
Country
Canada
Facility Name
Local Site # 124006
City
Windsor
Country
Canada
Facility Name
Local Site # 616015
City
Białystok
Country
Poland
Facility Name
Local Site # 616016
City
Białystok
Country
Poland
Facility Name
Local Site # 616001
City
Katowice
Country
Poland
Facility Name
Local Site # 616014
City
Kraków
Country
Poland
Facility Name
Local Site #616010
City
Lublin
Country
Poland
Facility Name
Local Site # 616011
City
Mikołów
Country
Poland
Facility Name
Local Site # 616009
City
Nowa Sól
Country
Poland
Facility Name
Local Site # 616003
City
Ostrowiec Świętokrzyski
Country
Poland
Facility Name
Local Site # 616008
City
Poznań
Country
Poland
Facility Name
Local Site # 616007
City
Szczecin
Country
Poland
Facility Name
Local Site # 616013
City
Szczecin
Country
Poland
Facility Name
Local Site # 616005
City
Warszawa
Country
Poland
Facility Name
Local Site # 616002
City
Wrocław
Country
Poland
Facility Name
Local Site # 616006
City
Wrocław
Country
Poland
Facility Name
Local Site # 616018
City
Wrocław
Country
Poland
Facility Name
Local Site # 616004
City
Łódź
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis

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