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A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

Study Purpose

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Study participant must be at least 19 years of age at the time of signing the informed consent.
  • - Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO) - Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit.
  • - Study participant must have Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5-point scale.
  • - Study participant must be a candidate for systemic PSO therapy and/or phototherapy.
  • - Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs.
  • - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: - Not a female of childbearing potential (FOCBP) OR A FOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 20 weeks after the last dose of study treatment.

Exclusion Criteria:

  • - Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections.
  • - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection.
  • - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
  • - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.
  • - Study participant has a presence of active suicidal ideation or positive suicide behavior.
  • - Study participant has a presence of moderately severe major depression or severe major depression.
  • - Subject has a known hypersensitivity to any excipients of bimekizumab.
- Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05020249
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Moderate to Severe Plaque Psoriasis
Arms & Interventions

Arms

Experimental: Bimekizumab arm

Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.

Placebo Comparator: Placebo arm

Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.

Interventions

Drug: - bimekizumab

Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Other: - Placebo

Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ps0032 20211, Bucheon-si, Korea, Republic of

Status

Recruiting

Address

Ps0032 20211

Bucheon-si, ,

Ps0032 20214, Busan, Korea, Republic of

Status

Recruiting

Address

Ps0032 20214

Busan, ,

Ps0032 20215, Gwangju, Korea, Republic of

Status

Recruiting

Address

Ps0032 20215

Gwangju, ,

Ps0032 20208, Seongnam-si, Korea, Republic of

Status

Active, not recruiting

Address

Ps0032 20208

Seongnam-si, ,

Ps0032 20210, Seongnam-si, Korea, Republic of

Status

Recruiting

Address

Ps0032 20210

Seongnam-si, ,

Ps0032 20104, Seoul, Korea, Republic of

Status

Completed

Address

Ps0032 20104

Seoul, ,

Ps0032 20138, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Ps0032 20138

Seoul, ,

Ps0032 20213, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Ps0032 20213

Seoul, ,

Ps0032 20216, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Ps0032 20216

Seoul, ,

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