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

UCB

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Treatments: Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06011733

PS0041

Details and patient eligibility

About

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).

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups, including a placebo group

bimekizumab

Experimental group

Description:

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).

Treatment:

Other: Placebo

Drug: Bimekizumab

placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo

Drug: Bimekizumab