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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2022-09-06

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.

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Detailed Description

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Conditions

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Moderate to Severe Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bimekizumab arm

Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.

Group Type EXPERIMENTAL

bimekizumab

Intervention Type DRUG

Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Placebo arm

Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Interventions

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bimekizumab

Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Intervention Type DRUG

Placebo

Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Intervention Type OTHER

Other Intervention Names

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BKZ UCB4940 PBO

Eligibility Criteria

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Inclusion Criteria

* Study participant must be at least 19 years of age at the time of signing the informed consent
* Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO)
* Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit
* Study participant must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
* Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
* A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
* Not a female of childbearing potential (FOCBP) OR A FOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 20 weeks after the last dose of study treatment

Exclusion Criteria

* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
* Study participant has a presence of active suicidal ideation or positive suicide behavior
* Study participant has a presence of moderately severe major depression or severe major depression
* Subject has a known hypersensitivity to any excipients of bimekizumab
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No