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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZP9830, Placebo.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug ZP9830
Participants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm - Drug Placebo
Participants will receive multiple doses of placebo
Primary outcome measures
- Number of Treatment Emergent Adverse Events (TEAEs) [Time frame: From baseline (Day 1, predose) to follow-up (Day 85)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Centre for Human Drug Research — Leiden
Identifiers
NCT: NCT07733089 · ZP9830-25204 · 2026-525220-15-00 · WHO, UTN number