Mild to Moderate PsoriasisPhase 1NCT07849894
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UCB0159 in Participants With Mild to Moderate Psoriasis, Single Dose Pharmacokinetics and Safety in Healthy Participants.
A Phase 1 study testing UCB0159 in people with Mild to Moderate Psoriasis and Healthy Volunteers, run by UCB Biopharma SRL at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety and pharmacokinetics of UCB0159 administered in participants with mild to moderate plaque psoriasis and evaluate single dose pharmacokinetics and safety of UCB0159 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Psoriasis, Healthy Volunteers
- What is being tested?
- UCB0159
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jun 2017to 8 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants (healthy and participants with mild to moderate plaque PSO):
- Participant is male or female, aged >=18 years to <=70 years at Screening.
- Participant is considered reliable and capable of adhering to the protocol.
- Female participants must either be postmenopausal, permanently sterilized or congenitally sterile. Female participants of childbearing potential must agree to use a highly effective method of birth control during the study period (from dosing until the Safety follow up (SFU) Visit) and for a period of 6 months after dosing of investigational medicinal product (IMP).
- Male Participant confirms that during the study period and for a period of 6 months, or, when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier (eg, condom without spermicide or fat- or oil containing lubricants) AND an additional highly effective contraceptive method (as listed below) by the female partner.
- Participant has a body mass index between 18 and <=35kilograms (kg)/m^2 and a minimum body weight of 45kg (female participants) and 50kg (male participants) at Screening.
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- Participant is in good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening and at Baseline.
- Participants with mild to moderate plaque Psoriasis:
- Confirmed diagnosis of mild to moderate plaque-type Psoriasis for at least 6 months involving <10 percent (%) of body surface area (BSA) (excluding the scalp).
- Minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
- Exclusion Criteria: All Participants (healthy and participants with mild to moderate plaque PSO):
- Participant has received an IMP within the last 3 months or 5 half-lives prior to Screening, whichever is longer.
- Participant has a known hypersensitivity reaction to any components of the IMP (polysorbate 80, histidine, and/or proline).
- Participant has donated more than 400 milliliters (mL) of blood or blood products within 90 days prior to check in (Day -2) or plans to donate blood during the study.
- Participant has an active or recurrent clinically significant infection (eg, sepsis, pneumonia, or abscess) or has had a serious or opportunistic infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration.
- Participant with known active tuberculosis (TB) disease, with a past history of active TB involving any organ system, participant with current or history of nontuberculous mycobacterial (NTMB) infection despite prior or current therapy, participants at high risk of acquiring TB infection.
- Participant with latent TB infection (LTBI).
- Participant has received live attenuated vaccination within 8 weeks prior to Screening or intends to have such a vaccination during the course of the study or within 12 weeks after the dose of study drug.
- Participant has a positive hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to Screening.
- Participant has a positive test for human immunodeficiency virus (HIV) antibody.
- Participants with mild to moderate plaque Psoriasis:
- Participant has received systemic nonbiologic PSO therapy (methotrexate [MTX], steroids, or cyclophosphamide), phytotherapy, or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
- Participant has received alefacept within 24 months prior to Screening.
- Participant has received treatment with biological agents other than alefacept, eg, adalimumab, efalizumab, etanercept, infliximab, ustekinumab, or bimekizumab within 12 weeks prior to Screening.
- Participant has a history or current evidence of autoimmune disease other than PSO
- Participant has any other acute or chronic illness which, in the opinion of the Investigator or Study Physician, could pose a threat or harm to the Participant.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Single-Dose, Dose-Escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB0159 in Subjects With Mild to Moderate Psoriasis, and Single-Dose Pharmacokinetics and Safety in Healthy Subjects
The purpose of the study is to evaluate the safety and pharmacokinetics of UCB0159 administered in participants with mild to moderate plaque psoriasis and evaluate single dose pharmacokinetics and safety of UCB0159 in healthy participants.
- Conditions
- Mild to Moderate Psoriasis, Healthy Volunteers
- Being tested
- UCB0159, Placebo
- Keywords
- Mild to moderate Psoriasis, Healthy volunteers, UCB0159
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0159Drug
Different dosages will be provided.
PlaceboOther
Placebo will be provided matching UCB0159 to maintain the blinding.
| Study group | Role | What they receive |
|---|---|---|
| UCB0159 dosing regimen | Experimental | Participants randomized into the UCB0159 dosing regimen will receive different dosages of UCB0159 at pre-defined time points. Receives: Drug: UCB0159 |
| Placebo | Placebo comparator | Participants randomized into the Placebo arm will receive placebo at pre-defined time points to maintain the blinding. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events from the Screening Visit through the Safety-Follow Up Visit
An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a investigational medicinal product, whether or not related to the investigational medicinal product.
Measured: From Screening Visit through Safety Follow-Up Visit (up to Day 85)
Cmax: maximum serum concentration of UCB0159
Cmax: maximum serum concentration of UCB0159
Measured: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
tmax: time to reach maximum serum concentration of UCB0159
tmax: time to reach maximum serum concentration of UCB0159
Measured: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
AUC(0-t): Area under the UCB0159 concentration-time curve from time 0 to time t, time of last quantifiable concentration
AUC(0-t): Area under the UCB0159 concentration-time curve from time 0 to time t, time of last quantifiable concentration
Measured: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start23 Jun 2017
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate PsoriasisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849894
- Sponsor's protocol ID
- PS0019
- Other IDs
- 2017-000168-14, 2017
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Single-Dose, Dose-Escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB0159 in Subjects With Mild to Moderate Psoriasis, and Single-Dose Pharmacokinetics and Safety in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07849894
- Acronym / sponsor ID
- PS0019
- Conditions
- Mild to Moderate Psoriasis, Healthy Volunteers
- Keywords
- Mild to moderate Psoriasis, Healthy volunteers, UCB0159
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 30 Sep 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 the study is to evaluate the safety and pharmacokinetics of UCB0159 administered in participants with mild to moderate plaque psoriasis and evaluate single dose pharmacokinetics and safety of UCB0159 in healthy participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB0159 dosing regimen | Experimental | Drug: UCB0159Participants randomized into the UCB0159 dosing regimen will receive different dosages of UCB0159 at pre-defined time points. |
| Placebo | Placebo comparator | Other: PlaceboParticipants randomized into the Placebo arm will receive placebo at pre-defined time points to maintain the blinding. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participant is male or female, aged >=18 years to <=70 years at Screening.
- Participant is considered reliable and capable of adhering to the protocol.
- Female participants must either be postmenopausal, permanently sterilized or congenitally sterile. Female participants of childbearing potential must agree to use a highly effective method of birth control during the study period (from dosing until the Safety follow up (SFU) Visit) and for a period of 6 months after dosing of investigational medicinal product (IMP).
- Male Participant confirms that during the study period and for a period of 6 months, or, when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier (eg, condom without spermicide or fat- or oil containing lubricants) AND an additional highly effective contraceptive method (as listed below) by the female partner.
- Participant has a body mass index between 18 and <=35kilograms (kg)/m^2 and a minimum body weight of 45kg (female participants) and 50kg (male participants) at Screening.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| UCB0159Different dosages will be provided. | Drug | UCB0159 dosing regimen |
| PlaceboPlacebo will be provided matching UCB0159 to maintain the blinding. | Other | Placebo |
Primary outcome
Number of Adverse Events from the Screening Visit through the Safety-Follow Up Visit
Time frame: From Screening Visit through Safety Follow-Up Visit (up to Day 85)
An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a investigational medicinal product, whether or not related to the investigational medicinal product.
Cmax: maximum serum concentration of UCB0159
Time frame: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
Cmax: maximum serum concentration of UCB0159
tmax: time to reach maximum serum concentration of UCB0159
Time frame: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
tmax: time to reach maximum serum concentration of UCB0159
AUC(0-t): Area under the UCB0159 concentration-time curve from time 0 to time t, time of last quantifiable concentration
Time frame: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)
AUC(0-t): Area under the UCB0159 concentration-time curve from time 0 to time t, time of last quantifiable concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Related trials for Mild to Moderate Psoriasis
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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. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB0159 in people with Mild to Moderate Psoriasis and Healthy Volunteers, run by UCB Biopharma SRL at 2 sites in 2 countries.
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 26 inclusion and 0 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events from the Screening Visit through the Safety-Follow Up Visit (time frame: From Screening Visit through Safety Follow-Up Visit (up to Day 85)). The study lists 4 primary outcomes in all. 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 30 Sep 2026.