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CompletedNCT07849894Updated Sep 30, 2026

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 interventional study of UCB0159 and Placebo in Mild to Moderate Psoriasis and Healthy Volunteers, sponsored by UCB Biopharma SRL. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 years 3 months after the study started (first participant enrolled Jun 2017, registered Sep 2026).
Updated Sep 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mild to Moderate Psoriasis
  • Healthy Volunteers

Keywords

  • Mild to moderate Psoriasis
  • Healthy volunteers
  • UCB0159
03

In context

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    UCB0159 dosing regimen

    Participants randomized into the UCB0159 dosing regimen will receive different dosages of UCB0159 at pre-defined time points.

    Drug: UCB0159

  • Placebo comparator
    Placebo

    Participants randomized into the Placebo arm will receive placebo at pre-defined time points to maintain the blinding.

    Other: Placebo

Interventions

  • DrugUCB0159

    Different dosages will be provided.

  • OtherPlacebo

    Placebo will be provided matching UCB0159 to maintain the blinding.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Screening Visit through Safety Follow-Up Visit (up to Day 85)

  2. Cmax: maximum serum concentration of UCB0159

    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)

  3. tmax: time to reach 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)

  4. 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

    Time frame: Samples will be collected predose (Day -1) and postdose at predefined time points (Day 1 to Day 85)

07

Study locations

2 sites
  • PS0019 2
    Berlin, Germany
  • PS0019 1
    Harrow, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07849894
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Jun 23, 2017
Primary completion
Dec 8, 2018
Completion
Dec 8, 2018
Last update
Sep 30, 2026

Study contacts

UCB Cares
study director · 001 844 599 2273

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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