VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
NCT ID: NCT05655299
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
222 participants
INTERVENTIONAL
2022-11-17
2023-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VTX958 Dose A
VTX958 Dose A
Dose A
VTX958 Dose B
VTX958 Dose B
Dose B
VTX958 Dose C
VTX958 Dose C
Dose C
VTX958 Dose D
VTX958 Dose D
Dose D
Placebo
Placebo
Placebo
Interventions
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VTX958 Dose A
Dose A
VTX958 Dose B
Dose B
VTX958 Dose C
Dose C
VTX958 Dose D
Dose D
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ventyx Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Snehal Naik, PhD
Role: STUDY_DIRECTOR
Ventyx Biosciences, Inc
Locations
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Local Site # 840012
Birmingham, Alabama, United States
Local Site # 840006
Birmingham, Alabama, United States
Local Site # 840028
Phoenix, Arizona, United States
Local Site # 840032
Bryant, Arkansas, United States
Local Site # 840041
North Little Rock, Arkansas, United States
Local Site # 840031
Fountain Valley, California, United States
Local Site # 840026
Lomita, California, United States
Local Site # 840019
Santa Rosa, California, United States
Local Site # 840003
Sherman Oaks, California, United States
Local Site # 840040
Boca Raton, Florida, United States
Local Site # 840011
Doral, Florida, United States
Local Site # 840023
Hialeah, Florida, United States
Local Site # 840021
Miami Lakes, Florida, United States
Local Site # 840044
North Miami Beach, Florida, United States
Local Site # 840010
Ocala, Florida, United States
Local Site # 840004
Tampa, Florida, United States
Local Site # 840001
Tampa, Florida, United States
Local Site # 840045
West Palm Beach, Florida, United States
Local Site # 840029
Marietta, Georgia, United States
Local Site # 840035
Clarksville, Indiana, United States
Local Site # 840005
Indianapolis, Indiana, United States
Local Site # 840030
Plainfield, Indiana, United States
Local Site # 840013
Louisville, Kentucky, United States
Local Site # 840022
Rockville, Maryland, United States
Local Site # 840008
Brighton, Massachusetts, United States
Local Site # 840016
Bay City, Michigan, United States
Local Site # 840007
Fort Gratiot, Michigan, United States
Local Site # 840002
Troy, Michigan, United States
Local Site # 840034
New Brighton, Minnesota, United States
Local Site # 840024
Saint Joseph, Missouri, United States
Local Site # 840027
Portsmouth, New Hampshire, United States
Local Site # 840042
Wilmington, North Carolina, United States
Local Site # 840037
Mason, Ohio, United States
Local Site # 840009
Portland, Oregon, United States
Local Site # 840038
Rapid City, South Dakota, United States
Local Site # 840015
Murfreesboro, Tennessee, United States
Local Site # 840039
Pflugerville, Texas, United States
Local Site # 840014
Spokane, Washington, United States
Local Site # 124012
Fredericton, , Canada
Local Site # 124010
Mississauga, , Canada
Local Site # 124002
Montreal, , Canada
Local Site # 124004
North Bay, , Canada
Local Site # 124011
Oshawa, , Canada
Local Site # 124007
Peterborough, , Canada
Local Site # 124008
Québec, , Canada
Local Site # 124005
Toronto, , Canada
Local Site # 124006
Windsor, , Canada
Local Site # 616015
Bialystok, , Poland
Local Site # 616016
Bialystok, , Poland
Local Site # 616001
Katowice, , Poland
Local Site # 616014
Krakow, , Poland
Local Site # 616004
Lodz, , Poland
Local Site #616010
Lublin, , Poland
Local Site # 616011
Mikołów, , Poland
Local Site # 616009
Nowa Sól, , Poland
Local Site # 616003
Ostrowiec Świętokrzyski, , Poland
Local Site # 616008
Poznan, , Poland
Local Site # 616007
Szczecin, , Poland
Local Site # 616013
Szczecin, , Poland
Local Site # 616005
Warsaw, , Poland
Local Site # 616002
Wroclaw, , Poland
Local Site # 616006
Wroclaw, , Poland
Local Site # 616018
Wroclaw, , Poland
Countries
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Other Identifiers
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VTX958-201
Identifier Type: -
Identifier Source: org_study_id
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