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

NCT ID: NCT06011733

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-02-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: 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

Intervention Type: 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.

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

BKZ

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

Ps0041 20023

Beijing, , China

Ps0041 20247

Beijing, , China

Ps0041 20306

Beijing, , China

Ps0041 20117

Guangzhou, , China

Ps0041 20311

Guangzhou, , China

Ps0041 20313

Guangzhou, , China

Ps0041 20022

Hangzhou, , China

Ps0041 20193

Hangzhou, , China

Ps0041 20296

Hangzhou, , China

Ps0041 20312

Jinan, , China

Ps0041 20318

Jinan, , China

Ps0041 20310

Ningbo, , China

Ps0041 20308

Shanghai, , China

Ps0041 20184

Shenzhen, , China

Ps0041 20136

Tianjin, , China

Ps0041 20120

Wuhan, , China

Ps0041 20314

Wuxi, , China

Ps0041 20309

Xi'an, , China

Countries

China

Other Identifiers

PS0041

Identifier Type: -

Identifier Source: org_study_id