VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05655299
• Other study ID #: VTX958-201
• Status: Terminated
• Phase: Phase 2
• Start date: November 17, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Ventyx Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: December 20, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• VTX958
Dose A
• VTX958
Dose B
• VTX958
Dose C
• VTX958
Dose D
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Local Site # 124012	Fredericton
Canada	Local Site # 124010	Mississauga
Canada	Local Site # 124002	Montréal
Canada	Local Site # 124004	North Bay
Canada	Local Site # 124011	Oshawa
Canada	Local Site # 124007	Peterborough
Canada	Local Site # 124008	Québec City
Canada	Local Site # 124005	Toronto
Canada	Local Site # 124006	Windsor
Poland	Local Site # 616015	Bialystok
Poland	Local Site # 616016	Bialystok
Poland	Local Site # 616001	Katowice
Poland	Local Site # 616014	Kraków
Poland	Local Site # 616004	Lódz
Poland	Local Site #616010	Lublin
Poland	Local Site # 616011	Mikolów
Poland	Local Site # 616009	Nowa Sól
Poland	Local Site # 616003	Ostrowiec Swietokrzyski
Poland	Local Site # 616008	Poznan
Poland	Local Site # 616007	Szczecin
Poland	Local Site # 616013	Szczecin
Poland	Local Site # 616005	Warszawa
Poland	Local Site # 616002	Wroclaw
Poland	Local Site # 616006	Wroclaw
Poland	Local Site # 616018	Wroclaw
United States	Local Site # 840016	Bay City	Michigan
United States	Local Site # 840006	Birmingham	Alabama
United States	Local Site # 840012	Birmingham	Alabama
United States	Local Site # 840040	Boca Raton	Florida
United States	Local Site # 840008	Brighton	Massachusetts
United States	Local Site # 840032	Bryant	Arkansas
United States	Local Site # 840035	Clarksville	Indiana
United States	Local Site # 840011	Doral	Florida
United States	Local Site # 840007	Fort Gratiot	Michigan
United States	Local Site # 840031	Fountain Valley	California
United States	Local Site # 840023	Hialeah	Florida
United States	Local Site # 840005	Indianapolis	Indiana
United States	Local Site # 840026	Lomita	California
United States	Local Site # 840013	Louisville	Kentucky
United States	Local Site # 840029	Marietta	Georgia
United States	Local Site # 840037	Mason	Ohio
United States	Local Site # 840021	Miami Lakes	Florida
United States	Local Site # 840015	Murfreesboro	Tennessee
United States	Local Site # 840034	New Brighton	Minnesota
United States	Local Site # 840041	North Little Rock	Arkansas
United States	Local Site # 840044	North Miami Beach	Florida
United States	Local Site # 840010	Ocala	Florida
United States	Local Site # 840039	Pflugerville	Texas
United States	Local Site # 840028	Phoenix	Arizona
United States	Local Site # 840030	Plainfield	Indiana
United States	Local Site # 840009	Portland	Oregon
United States	Local Site # 840027	Portsmouth	New Hampshire
United States	Local Site # 840038	Rapid City	South Dakota
United States	Local Site # 840022	Rockville	Maryland
United States	Local Site # 840024	Saint Joseph	Missouri
United States	Local Site # 840019	Santa Rosa	California
United States	Local Site # 840003	Sherman Oaks	California
United States	Local Site # 840014	Spokane	Washington
United States	Local Site # 840001	Tampa	Florida
United States	Local Site # 840004	Tampa	Florida
United States	Local Site # 840002	Troy	Michigan
United States	Local Site # 840045	West Palm Beach	Florida
United States	Local Site # 840042	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ventyx Biosciences, Inc

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	PASI Efficacy at 16 weeks	Proportion of participants achieving PASI-90 at Week 16	Day 1 of Placebo-controlled treatment period to week 16
Secondary	PASI Efficacy at 16 weeks	Proportion of participants achieving PASI-100 at Week 16	Day 1 of Placebo-controlled treatment period to week 16
Secondary	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
Secondary	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