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Chronic Plaque PsoriasisPhase 3BE SHININGNCT06011733

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

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bimekizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
18 sitesChina
Study dates
31 Oct 2023to 5 Feb 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Ps0041 20023

    Beijing

  • Ps0041 20247

    Beijing

  • Ps0041 20306

    Beijing

  • Ps0041 20117

    Guangzhou

  • Ps0041 20311

    Guangzhou

  • Ps0041 20313

    Guangzhou

  • Ps0041 20022

    Hangzhou

  • Ps0041 20193

    Hangzhou

  • Ps0041 20296

    Hangzhou

  • Ps0041 20312

    Jinan

  • Ps0041 20318

    Jinan

  • Ps0041 20310

    Ningbo

  • Ps0041 20308

    Shanghai

  • Ps0041 20184

    Shenzhen

  • Ps0041 20136

    Tianjin

  • Ps0041 20120

    Wuhan

  • Ps0041 20314

    Wuxi

  • Ps0041 20309

    Xi'an

Other trials in China

About this study

Official title: 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).

Being tested
Placebo, Bimekizumab
Keywords
Psoriasis, PSO, Bimekizumab, Chinese Adults Study Participants
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    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.

  • BimekizumabDrug

    Also called BKZ

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

Study groups in NCT06011733
Study groupRoleWhat they receive
bimekizumabExperimentalStudy 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).
Receives: Other: Placebo; Drug: Bimekizumab
placeboPlacebo comparatorStudy 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).
Receives: Other: Placebo; Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at 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.

    Measured: Week 16

  2. Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at 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.

    Measured: Week 16

Secondary outcomes (8)

  1. Percentage of Participants With PASI75 Response at 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.

    Measured: Week 4

  2. Percentage of Participants With PASI100 Response at 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.

    Measured: Week 16

  3. Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at 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.

    Measured: Week 16

  4. Percentage of Participants With PSD P-SIM Response for Pain at 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.

    Measured: Week 16

  5. Percentage of Participants With PSD P-SIM Response for Scaling at 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.

    Measured: Week 16

  6. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through 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.

    Measured: From Baseline to End of Initial Treatment Period (up to Week 16)

  7. Percentage of Participants With Serious TEAEs Through 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.

    Measured: From Baseline to End of Initial Treatment Period (up to Week 16)

  8. Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through 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.

    Measured: From Baseline to End of Initial Treatment Period (up to Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study start31 Oct 2023
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06011733
Sponsor's protocol ID
PS0041
Acronym
BE SHINING
Status last verified
May 2026
First submitted
21 Aug 2023
Last updated
26 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Cai L, Man XY, Wang J, Wei A, Chen Y, Deherder D, Gao J, Hoepken B, Sun W, Lei T, Zhang J; BE SHINING Study Group. Bimekizumab efficacy and safety in Chinese patients with psoriasis in the BE SHINING Phase 3 study. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1019-1029. doi: 10.1111/jdv.70350. Epub 2026 Feb 12.

    PubMed 41678327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06011733, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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