Clinical trial NCT05020249: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Moderate to Severe Plaque Psoriasis
Korean Study Participants
BKZ
UCB4940
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline
timeFrame: Week 16
measure: Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16
timeFrame: Week 16
measure: Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
timeFrame: From Baseline to End of Safety Follow-Up (SFU) (up to Week 32)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study
timeFrame: From Baseline to End of Safety Follow-Up (up to Week 32)
measure: Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study
timeFrame: From Baseline to End of Safety Follow-Up (up to Week 32)
measure: Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Ps0032 20211
city: Busan
country: Korea, Republic of
facility: Ps0032 20214
city: Gwangju
country: Korea, Republic of
facility: Ps0032 20215
city: Seongnam-si
country: Korea, Republic of
facility: Ps0032 20208
city: Seongnam-si
country: Korea, Republic of
facility: Ps0032 20210
city: Seoul
country: Korea, Republic of
facility: Ps0032 20104
city: Seoul
country: Korea, Republic of
facility: Ps0032 20138
city: Seoul
country: Korea, Republic of
facility: Ps0032 20213
city: Seoul
country: Korea, Republic of
facility: Ps0032 20216
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Youn SW, Jo SJ, Park CJ, Kim DH, Shin BS, Jeong KH, Bang CH, Cross N, Thirlwell J, Hoepken B. Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study. J Dermatol. 2024 Nov;51(11):1392-1403. doi: 10.1111/1346-8138.17446. Epub 2024 Sep 27.