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

UCB

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05020249

PS0032

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 2 patient groups, including a placebo group

Bimekizumab arm

Experimental group

Description:

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

Treatment:

Drug: bimekizumab

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo