Clinical trial NCT05655299: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriasis
Keywords: TYK2 inhibitor
moderate to severe psoriasis
Ventyx
VTX958
Lead sponsor: Ventyx Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 approximately 16 months.


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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
timeFrame: Screening through study completion, up to 76 weeks
Secondary outcomes:
measure: Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: PASI Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: PASI Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: PASI Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
measure: Body Surface Area (BSA) Efficacy at 16 weeks
timeFrame: Day 1 of Placebo-controlled treatment period to week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Site # 840012
state: Alabama
city: Birmingham
country: United States
facility: Local Site # 840006
state: Alabama
city: Phoenix
country: United States
facility: Local Site # 840028
state: Arizona
city: Bryant
country: United States
facility: Local Site # 840032
state: Arkansas
city: North Little Rock
country: United States
facility: Local Site # 840041
state: Arkansas
city: Fountain Valley
country: United States
facility: Local Site # 840031
state: California
city: Lomita
country: United States
facility: Local Site # 840026
state: California
city: Santa Rosa
country: United States
facility: Local Site # 840019
state: California
city: Sherman Oaks
country: United States
facility: Local Site # 840003
state: California
city: Boca Raton
country: United States
facility: Local Site # 840040
state: Florida
city: Doral
country: United States
facility: Local Site # 840011
state: Florida
city: Hialeah
country: United States
facility: Local Site # 840023
state: Florida
city: Miami Lakes
country: United States
facility: Local Site # 840021
state: Florida
city: North Miami Beach
country: United States
facility: Local Site # 840044
state: Florida
city: Ocala
country: United States
facility: Local Site # 840010
state: Florida
city: Tampa
country: United States
facility: Local Site # 840004
state: Florida
city: Tampa
country: United States
facility: Local Site # 840001
state: Florida
city: West Palm Beach
country: United States
facility: Local Site # 840045
state: Florida
city: Marietta
country: United States
facility: Local Site # 840029
state: Georgia
city: Clarksville
country: United States
facility: Local Site # 840035
state: Indiana
city: Indianapolis
country: United States
facility: Local Site # 840005
state: Indiana
city: Plainfield
country: United States
facility: Local Site # 840030
state: Indiana
city: Louisville
country: United States
facility: Local Site # 840013
state: Kentucky
city: Rockville
country: United States
facility: Local Site # 840022
state: Maryland
city: Brighton
country: United States
facility: Local Site # 840008
state: Massachusetts
city: Bay City
country: United States
facility: Local Site # 840016
state: Michigan
city: Fort Gratiot
country: United States
facility: Local Site # 840007
state: Michigan
city: Troy
country: United States
facility: Local Site # 840002
state: Michigan
city: New Brighton
country: United States
facility: Local Site # 840034
state: Minnesota
city: Saint Joseph
country: United States
facility: Local Site # 840024
state: Missouri
city: Portsmouth
country: United States
facility: Local Site # 840027
state: New Hampshire
city: Wilmington
country: United States
facility: Local Site # 840042
state: North Carolina
city: Mason
country: United States
facility: Local Site # 840037
state: Ohio
city: Portland
country: United States
facility: Local Site # 840009
state: Oregon
city: Rapid City
country: United States
facility: Local Site # 840038
state: South Dakota
city: Murfreesboro
country: United States
facility: Local Site # 840015
state: Tennessee
city: Pflugerville
country: United States
facility: Local Site # 840039
state: Texas
city: Spokane
country: United States
facility: Local Site # 840014
state: Washington
city: Fredericton
country: Canada
facility: Local Site # 124012
city: Mississauga
country: Canada
facility: Local Site # 124010
city: Montréal
country: Canada
facility: Local Site # 124002
city: North Bay
country: Canada
facility: Local Site # 124004
city: Oshawa
country: Canada
facility: Local Site # 124011
city: Peterborough
country: Canada
facility: Local Site # 124007
city: Québec City
country: Canada
facility: Local Site # 124008
city: Toronto
country: Canada
facility: Local Site # 124005
city: Windsor
country: Canada
facility: Local Site # 124006
city: Białystok
country: Poland
facility: Local Site # 616015
city: Białystok
country: Poland
facility: Local Site # 616016
city: Katowice
country: Poland
facility: Local Site # 616001
city: Kraków
country: Poland
facility: Local Site # 616014
city: Lublin
country: Poland
facility: Local Site #616010
city: Mikołów
country: Poland
facility: Local Site # 616011
city: Nowa Sól
country: Poland
facility: Local Site # 616009
city: Ostrowiec Świętokrzyski
country: Poland
facility: Local Site # 616003
city: Poznań
country: Poland
facility: Local Site # 616008
city: Szczecin
country: Poland
facility: Local Site # 616007
city: Szczecin
country: Poland
facility: Local Site # 616013
city: Warszawa
country: Poland
facility: Local Site # 616005
city: Wrocław
country: Poland
facility: Local Site # 616002
city: Wrocław
country: Poland
facility: Local Site # 616006
city: Wrocław
country: Poland
facility: Local Site # 616018
city: Łódź
country: Poland
facility: Local Site # 616004
Study officials:
affiliation: Ventyx Biosciences, Inc
name: Snehal Naik, PhD
role: STUDY_DIRECTOR
References: