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.
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.
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.
Parallel
ZP9830
DrugParticipants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm
Placebo
DrugParticipants will receive multiple doses of placebo
Number of Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of ZP9830 following administration of multiple doses in participants with plaque psoriasis.
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Zealand Pharma
Lead sponsor
Centre for Human Drug Research, Netherlands
Collaborator
ICON Clinical Research
Collaborator
