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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZealand Pharma

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ZP9830
  • Placebo

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zealand Pharma

Lead sponsor

Centre for Human Drug Research, Netherlands

Collaborator

ICON Clinical Research

Collaborator