Plaque PsoriasisPhase 1NCT07733089
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
A Phase 1 study testing ZP9830 in people with Plaque Psoriasis, run by Zealand Pharma at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ZP9830
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research
Leiden, South Holland, 2333 CL
Robert Rissmann, +31 71 5246 400, clintrials@chdr.nl
Robert Rissmann
About this study
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
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.
- Conditions
- Plaque Psoriasis
- Being tested
- ZP9830, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP9830Drug
Participants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm
PlaceboDrug
Participants will receive multiple doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| ZP9830 | Experimental | The experimental arm is divided into two treatment arms with different dose frequencies. Receives: Drug: ZP9830 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 1, predose) to follow-up (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start22 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands, ICON Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733089
- Sponsor's protocol ID
- ZP9830-25204
- Other IDs
- 2026-525220-15-00, WHO, UTN number
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07733089
- Acronym / sponsor ID
- ZP9830-25204
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands, ICON Clinical Research
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZP9830 | Experimental | Drug: ZP9830The experimental arm is divided into two treatment arms with different dose frequencies. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZP9830Participants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm | Drug | ZP9830 |
| PlaceboParticipants will receive multiple doses of placebo | Drug | Placebo |
Primary outcome
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (Day 1, predose) to follow-up (Day 85)
To evaluate the safety and tolerability of ZP9830 following administration of multiple doses in participants with plaque psoriasis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZP9830 in people with Plaque Psoriasis, run by Zealand Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (+45 88 77 36 00, clinicaltrials@zealandpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (TEAEs) (time frame: From baseline (Day 1, predose) to follow-up (Day 85)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.