VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis

Launched by VENTYX BIOSCIENCES, INC · Dec 8, 2022

Keywords

ClinConnect Summary

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Gender

ALL

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.

Trial Officials