How safe and well ZP9830 works in people with plaque psoriasis over 8 weeks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1 trial evaluates repeated administration of ZP9830 over an 8-week treatment period in adults with stable plaque psoriasis. The study primarily assesses safety and tolerability, and also explores preliminary clinical efficacy, pharmacokinetics, and pharmacodynamics. Participants are randomized to receive ZP9830 or placebo, with careful monitoring for adverse events and treatment effects. Eligible participants have confirmed plaque psoriasis with at least two plaques and a body mass index between 18 and 35 kg/m2. The trial is conducted at the Centre for Human Drug Research in Leiden, with Zealand Pharma as the lead sponsor and collaborators from CHDR and ICON Clinical Research.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre for Human Drug Research
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: clinicaltrials@zealandpharma.com
• Phone: +45 88 77 36 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.