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

NCT06011733 | Completed Phase 3 Results

• 1 other identifier: PS0041
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 18

Brief 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).

Conditions

Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Keywords

Psoriasis; PSO; Bimekizumab; Chinese Adults Study Participants

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 16

• 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.

  Week 16

Secondary Outcomes (8)

• Percentage of Participants With PASI75 Response at Week 4

  Week 4

• Percentage of Participants With PASI100 Response at Week 16

  Week 16

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

  Week 16

• Percentage of Participants With PSD P-SIM Response for Pain at Week 16

  Week 16

• Percentage of Participants With PSD P-SIM Response for Scaling at Week 16

  Week 16

Study Arms (2)

bimekizumab

EXPERIMENTAL

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; Drug: Bimekizumab

placebo

PLACEBO COMPARATOR

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; Drug: Bimekizumab

Interventions

Placebo OTHER

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.

bimekizumab; placebo

Bimekizumab DRUG

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

Also known as: BKZ

bimekizumab; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (18)

Ps0041 20023

Beijing, China

Location

Ps0041 20247

Beijing, China

Location

Ps0041 20306

Beijing, China

Location

Ps0041 20117

Guangzhou, China

Location

Ps0041 20311

Guangzhou, China

Location

Ps0041 20313

Guangzhou, China

Location

Ps0041 20022

Hangzhou, China

Location

Ps0041 20193

Hangzhou, China

Location

Ps0041 20296

Hangzhou, China

Location

Ps0041 20312

Jinan, China

Location

Ps0041 20318

Jinan, China

Location

Ps0041 20310

Ningbo, China

Location

Ps0041 20308

Shanghai, China

Location

Ps0041 20184

Shenzhen, China

Location

Ps0041 20136

Tianjin, China

Location

Ps0041 20120

Wuhan, China

Location

Ps0041 20314

Wuxi, China

Location

Ps0041 20309

Xi'an, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: October 31, 2023
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

CN (18)