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

June 1, 2026 updated by: UCB Biopharma SRL

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Ps0041 20023
      • Beijing, China
        • Ps0041 20247
      • Beijing, China
        • Ps0041 20306
      • Guangzhou, China
        • Ps0041 20117
      • Guangzhou, China
        • Ps0041 20311
      • Guangzhou, China
        • Ps0041 20313
      • Hangzhou, China
        • Ps0041 20022
      • Hangzhou, China
        • Ps0041 20193
      • Hangzhou, China
        • Ps0041 20296
      • Jinan, China
        • Ps0041 20312
      • Jinan, China
        • Ps0041 20318
      • Ningbo, China
        • Ps0041 20310
      • Shanghai, China
        • Ps0041 20308
      • Shenzhen, China
        • Ps0041 20184
      • Tianjin, China
        • Ps0041 20136
      • Wuhan, China
        • Ps0041 20120
      • Wuxi, China
        • Ps0041 20314
      • Xi'an, China
        • Ps0041 20309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
Other Names:
  • BKZ
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).
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.
Other Names:
  • BKZ

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16
Time Frame: Week 16
PASI90:at least 90% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided in 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling (each on 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked). Determining percentage of skin covered with PSO for each body areas and converting to 0 to 6 scale (0=none; 1=1% to less than [<] 10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0=no disease, maximum score 72=maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
Week 16
Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16
Time Frame: Week 16
The IGA measured the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Percentage of Participants with Investigator´s Global Assessment (IGA) 0/1 response at Week 16 is reported here. The percentage of participants data was rounded to one decimal place.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With PASI75 Response at Week 4
Time Frame: Week 4
PASI75 response: at least 75% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Percentage of skin covered with PSO for each region was converted to 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0= no disease, the maximum PASI score 72= maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
Week 4
Percentage of Participants With PASI100 Response at Week 16
Time Frame: Week 16
PASI100: 100% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each region scored for redness, thickness, and scaling (each on a 5 point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Determining percentage of skin covered with PSO for each of body areas and 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score= 0 (no disease), the maximum PASI score= 72 (maximal disease). Higher score indicated increased disease severity. The percentage of participants data was rounded to one decimal place.
Week 16
Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16
Time Frame: Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). PSD (P-SIM) response for itch at Week 16: participants were considered responders if itch score improved (decreased) by greater than or equal to (>=) 4 points from Baseline to Week 16 and study participant had not discontinued the investigational medicinal product (IMP) prior to Week 16. Percentage of participants data was rounded to one decimal place.
Week 16
Percentage of Participants With PSD P-SIM Response for Pain at Week 16
Time Frame: Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact. PSD (P-SIM) response for pain at Week 16: participants were considered responders if pain score improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
Week 16
Percentage of Participants With PSD P-SIM Response for Scaling at Week 16
Time Frame: Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/impact) and 10 (very severe symptom/worst impact. PSD (P-SIM) response for scaling at Week 16: participants were considered responders if scaling score had improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
Week 16
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16
Time Frame: From Baseline to End of Initial Treatment Period (up to Week 16)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
From Baseline to End of Initial Treatment Period (up to Week 16)
Percentage of Participants With Serious TEAEs Through Week 16
Time Frame: From Baseline to End of Initial Treatment Period (up to Week 16)
A SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in patient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.
From Baseline to End of Initial Treatment Period (up to Week 16)
Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16
Time Frame: From Baseline to End of Initial Treatment Period (up to Week 16)
Percentage of Participants with TEAEs leading to permanent discontinuation of IMP through Week 16 was reported. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
From Baseline to End of Initial Treatment Period (up to Week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma SRL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS0041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

IPD Sharing Time Frame

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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