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NCT05655299TerminatedPhase 2

VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Reason given: Business Decision

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
222 (actual)
First submitted
2 Dec 2022
Start date
17 Nov 2022
Primary completion date
25 Sept 2023
Lead sponsor
Ventyx Biosciences, Inc
Diseases
Psoriasis
NCT number
NCT05655299

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis.
  • 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.

Other illness

  • History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • 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.

Other

  • Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study.
  • Participant is known to have immune deficiency or is immunocompromised.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-FrederictonCanadaUnknown status
-MississaugaCanadaUnknown status
-MontrealCanadaUnknown status
-North BayCanadaUnknown status
-OshawaCanadaUnknown status
-PeterboroughCanadaUnknown status
-QuébecCanadaUnknown status
-TorontoCanadaUnknown status
-WindsorCanadaUnknown status
-BialystokPolandUnknown status
-BialystokPolandUnknown status
-KatowicePolandUnknown status
-KrakowPolandUnknown status
-LodzPolandUnknown status
-LublinPolandUnknown status
-MikołówPolandUnknown status
-Nowa SólPolandUnknown status
-Ostrowiec ŚwiętokrzyskiPolandUnknown status
-PoznanPolandUnknown status
-SzczecinPolandUnknown status
-SzczecinPolandUnknown status
-WarsawPolandUnknown status
-WroclawPolandUnknown status
-WroclawPolandUnknown status
-WroclawPolandUnknown status
-Bay CityUnited StatesUnknown status
-BirminghamUnited StatesUnknown status
-BirminghamUnited StatesUnknown status
-Boca RatonUnited StatesUnknown status
-BrightonUnited StatesUnknown status
-BryantUnited StatesUnknown status
-ClarksvilleUnited StatesUnknown status
-DoralUnited StatesUnknown status
-Fort GratiotUnited StatesUnknown status
-Fountain ValleyUnited StatesUnknown status
-HialeahUnited StatesUnknown status
-IndianapolisUnited StatesUnknown status
-LomitaUnited StatesUnknown status
-LouisvilleUnited StatesUnknown status
-MariettaUnited StatesUnknown status
-MasonUnited StatesUnknown status
-Miami LakesUnited StatesUnknown status
-MurfreesboroUnited StatesUnknown status
-New BrightonUnited StatesUnknown status
-North Little RockUnited StatesUnknown status
-North Miami BeachUnited StatesUnknown status
-OcalaUnited StatesUnknown status
-PflugervilleUnited StatesUnknown status
-PhoenixUnited StatesUnknown status
-PlainfieldUnited StatesUnknown status
-PortlandUnited StatesUnknown status
-PortsmouthUnited StatesUnknown status
-Rapid CityUnited StatesUnknown status
-RockvilleUnited StatesUnknown status
-Saint JosephUnited StatesUnknown status
-Santa RosaUnited StatesUnknown status
-Sherman OaksUnited StatesUnknown status
-SpokaneUnited StatesUnknown status
-TampaUnited StatesUnknown status
-TampaUnited StatesUnknown status
-TroyUnited StatesUnknown status
-West Palm BeachUnited StatesUnknown status
-WilmingtonUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.