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

Study Purpose

The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Study participant is Chinese male or female ≥18 years of age.
  • - Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit.
  • - Study participant has 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 is a candidate for systemic PSO therapy and/or phototherapy.
  • - Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose.

Exclusion Criteria:

  • - Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP.
  • - Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO) - Study participant has an active infection or history of infection(s) as defined in the protocol.
  • - Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist.
  • - Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA) - Study participant has presence of significant uncontrolled neuropsychiatric disorder.
Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.

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.

NCT06011733
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
Agency Class

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

Industry
Overall Status Recruiting
Countries China
Conditions

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

Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Arms & Interventions

Arms

Experimental: bimekizumab

Study participants randomized to this arm will receive bimekizumab (BKZ) dosage regimen 1 in the Initial Treatment Period (16 weeks) and switch to dosage regimen 2 and placebo to maintain the blinding in the Maintenance Treatment Period (16 weeks).

Placebo Comparator: placebo

Study participants randomized to this arm will receive placebo comparator in the Initial Treatment Period (16 weeks) and switch to bimekizumab dosage regimen 1 in the Maintenance Treatment Period (16 weeks).

Interventions

Other: - Placebo

Study participants will receive placebo subcutaneously at pre-specified time points in the placebo arm as comparator and in the bimekizumab arm to maintain the blinding.

Drug: - Bimekizumab

Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.

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

Ps0041 20023, Beijing, China

Status

Recruiting

Address

Ps0041 20023

Beijing, ,

Ps0041 20247, Beijing, China

Status

Recruiting

Address

Ps0041 20247

Beijing, ,

Ps0041 20306, Beijing, China

Status

Recruiting

Address

Ps0041 20306

Beijing, ,

Ps0041 20117, Guangzhou, China

Status

Recruiting

Address

Ps0041 20117

Guangzhou, ,

Ps0041 20311, Guangzhou, China

Status

Recruiting

Address

Ps0041 20311

Guangzhou, ,

Ps0041 20313, Guangzhou, China

Status

Recruiting

Address

Ps0041 20313

Guangzhou, ,

Ps0041 20022, Hangzhou, China

Status

Recruiting

Address

Ps0041 20022

Hangzhou, ,

Ps0041 20193, Hangzhou, China

Status

Recruiting

Address

Ps0041 20193

Hangzhou, ,

Ps0041 20296, Hangzhou, China

Status

Recruiting

Address

Ps0041 20296

Hangzhou, ,

Ps0041 20312, Jinan, China

Status

Recruiting

Address

Ps0041 20312

Jinan, ,

Ps0041 20318, Jinan, China

Status

Recruiting

Address

Ps0041 20318

Jinan, ,

Ps0041 20310, Ningbo, China

Status

Recruiting

Address

Ps0041 20310

Ningbo, ,

Ps0041 20308, Shanghai, China

Status

Recruiting

Address

Ps0041 20308

Shanghai, ,

Ps0041 20184, Shenzhen, China

Status

Recruiting

Address

Ps0041 20184

Shenzhen, ,

Ps0041 20136, Tianjin, China

Status

Recruiting

Address

Ps0041 20136

Tianjin, ,

Ps0041 20120, Wuhan, China

Status

Recruiting

Address

Ps0041 20120

Wuhan, ,

Ps0041 20314, Wuxi, China

Status

Recruiting

Address

Ps0041 20314

Wuxi, ,

Ps0041 20309, Xi'an, China

Status

Recruiting

Address

Ps0041 20309

Xi'an, ,

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