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.

NCT07849894 | Completed Phase 1

• 3 other identifiers: PS00192017-000168-142017
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Mild to Moderate Psoriasis; Healthy Volunteers

Keywords

Mild to moderate Psoriasis; Healthy volunteers; UCB0159

Outcome Measures

Primary Outcomes (4)

• 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.

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

• Cmax: maximum serum concentration of UCB0159

  Cmax: maximum serum concentration of UCB0159

  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

  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

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

Study Arms (2)

UCB0159 dosing regimen

EXPERIMENTAL

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

Drug: UCB0159

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

UCB0159 DRUG

Different dosages will be provided.

UCB0159 dosing regimen

Placebo OTHER

Placebo will be provided matching UCB0159 to maintain the blinding.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (2)

PS0019 2

Berlin, Germany

Location

PS0019 1

Harrow, United Kingdom

Location

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: June 23, 2017
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (1)