NCT06011733: BE SHINING

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

Completed Phase 3 Results posted Last updated 20 February 2026

What this trial tests

Phase 3 trial testing Placebo in Chronic Plaque Psoriasis in 133 participants. Completed in 5 February 2025.

Timeline

31 October 2023

Primary endpoint
5 February 2025

5 February 2025

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	133
Start date	31 October 2023
Primary completion	5 February 2025
Estimated completion	5 February 2025
Sites	18 locations across China

Drugs / interventions tested

• Placebo
• Bimekizumab (BIMEKIZUMAB) — full drug profile →

Conditions studied

• Chronic Plaque Psoriasis — all drugs for Chronic Plaque Psoriasis →
• Moderate to Severe Chronic Plaque Psoriasis — all drugs for Moderate to Severe Chronic Plaque Psoriasis →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

18 and older, any sex, with Chronic Plaque Psoriasis or Moderate to Severe Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 Primary · 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

Group	Value	95% CI
ITP: Placebo	3.0
ITP: BKZ Dosage Regimen 1	94.0

Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 Primary · 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 lesio

Group	Value	95% CI
ITP: Placebo	3.0
ITP: BKZ Dosage Regimen 1	92.0

Percentage of Participants With PASI75 Response at Week 4 Secondary · 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 rednes

Group	Value	95% CI
ITP: Placebo	3.0
ITP: BKZ Dosage Regimen 1	74.0

Percentage of Participants With PASI100 Response at Week 16 Secondary · 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,

Group	Value	95% CI
ITP: Placebo	0
ITP: BKZ Dosage Regimen 1	65.0

Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 Secondary · 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)

Group	Value	95% CI
ITP: Placebo	8.0
ITP: BKZ Dosage Regimen 1	84.1

Percentage of Participants With PSD P-SIM Response for Pain at Week 16 Secondary · 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 sy

Group	Value	95% CI
ITP: Placebo	14.3
ITP: BKZ Dosage Regimen 1	86.1

Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 Secondary · 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 sym

Group	Value	95% CI
ITP: Placebo	20.0
ITP: BKZ Dosage Regimen 1	91.6

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 Secondary · 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.

Group	Value	95% CI
ITP: Placebo	51.5
ITP: BKZ Dosage Regimen 1	62.0

Percentage of Participants With Serious TEAEs Through Week 16 Secondary · 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.

Group	Value	95% CI
ITP: Placebo	9.1
ITP: BKZ Dosage Regimen 1	1.0

Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 Secondary · 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.

Group	Value	95% CI
ITP: Placebo	3.0
ITP: BKZ Dosage Regimen 1	1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline through the final dose (Week 28) of IMP + 119 days (covering the 17-week SFU Visit, ie, up to 45 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ITP: Placebo

Serious: 3/33 (9%)

Deaths: 0/33

ITP: BKZ Dosage Regimen 1

Serious: 1/100 (1%)

Deaths: 0/100

ITP+MTP: BKZ Dosage Regimen 1

Serious: 4/130 (3%)

Deaths: 0/130

ITP+MTP: BKZ Dosage Regimen 2

Serious: 4/96 (4%)

Deaths: 0/96

Serious adverse events (13 terms)

Reaction	System	ITP: Placebo	ITP: BKZ Dosage Regimen 1	ITP+MTP: BKZ Dosage Regime…	ITP+MTP: BKZ Dosage Regime…
Hypertrophic anal papilla	Gastrointestinal disorders	—	—	—	—
Gastritis erosive	Gastrointestinal disorders	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—
Chronic tonsillitis	Infections and infestations	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—
Chemical poisoning	Injury, poisoning and procedural complications	—	—	—	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—	—
Ovarian cyst torsion	Reproductive system and breast disorders	—	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	ITP: Placebo	ITP: BKZ Dosage Regimen 1	ITP+MTP: BKZ Dosage Regime…	ITP+MTP: BKZ Dosage Regime…
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—
Latent tuberculosis	Infections and infestations	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—
Hyperlipidaemia	Metabolism and nutrition disorders	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—

Most-reported serious reactions: Hypertrophic anal papilla, Gastritis erosive, Ileus, Haemorrhoids, Chronic tonsillitis, Tendon rupture, Chemical poisoning, Adenocarcinoma of colon.

Data from ClinicalTrials.gov NCT06011733 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bimekizumab efficacy and safety in Chinese patients with psoriasis in the BE SHINING Phase 3 study.
   Cai L, Man XY, Wang J, Wei A, et al · · 2026 · cited 1× · PMID 41678327 · DOI 10.1111/jdv.70350