A Trial to Understand How Safe and Well Tolerated ZP9830 is and How it Works in People With Plaque Psoriasis Over an 8-week Treatment Period

Официальное название

An Interventional, Randomized, Double-blind, Placebo-controlled, Multiple Dose Trial Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Clinical Efficacy of ZP9830 Administered for 8 Weeks in Participants With Plaque Psoriasis

Обзор

The purpose of this trial is to investigate the effects of repeated administration of ZP9830 for 8 weeks in participants with plaque psoriasis. Here, the primary aim is to evaluate safety and tolerability of ZP9830, the secondary aims are to test clinical efficacy and pharmacokinetics, and lastly the exploratory aim is to test the pharmacodynamic effects of ZP9830 treatment.

Вмешательства

• Препарат ZP9830
  Participants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm
• Препарат Placebo
  Participants will receive multiple doses of placebo

Первичные конечные точки

• Number of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: From baseline (Day 1, predose) to follow-up (Day 85)]

Критерии участия

Критерии включения

• Participants with a confirmed diagnosis of psoriasis (stable plaque psoriasis ≥ 2 months).
• Participants who have ≥ 2 vulgar psoriatic plaques.
• BMI within the range 18.0-35.0 kg/m2 (inclusive).
• Further inclusion criteria apply.

Критерии исключения

• Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis.
• Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate).
• Any clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hematology, biochemistry, and urinalysis).
• Any clinically significant abnormal findings during the standardized neurological examination conducted at screening.
• Use of any concurrent systemic medications that could affect psoriasis or psoriasis evaluation, including corticosteroids, retinoids, cyclosporine, methotrexate, PDE4s (phosphodiesterase 4), or biologic agents within 30 days prior to IMP administration or planned to use during the course of the trial.
• Use of concurrent topical medications containing corticosteroids, retinoids, calcitriol or other topical medication relevant to psoriasis treatment (must be discontinued at least 2 weeks prior to baseline).
• Use of any biologic or advance systemic therapies for any autoimmune disease within the last 12 months.
• Use of UVA, PUVA, or UVB therapy and tanning beds within 4 weeks of baseline or during trial participation.
• Further exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Centre for Human Drug Research — Leiden

Идентификаторы

NCT: NCT07733089 · ZP9830-25204 · 2026-525220-15-00 · WHO, UTN number

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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