Clinical trial NCT06011733: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult 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 Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Keywords: Psoriasis
PSO
Bimekizumab
Chinese Adults Study Participants
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 16
timeFrame: Week 16
measure: Investigator´s Global Assessment (IGA) 0/1 response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: PASI75 response at Week 4
timeFrame: Week 4
measure: PASI100 response at Week 16
timeFrame: Week 16
measure: Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16
timeFrame: Week 16
measure: PSD (P-SIM) response for pain at Week 16
timeFrame: Week 16
measure: PSD (P-SIM) response for scaling at Week 16
timeFrame: Week 16
measure: Incidence of Treatment-emergent Adverse Events (TEAE)s through Week 16
timeFrame: From Baseline to End of initial Treatment Period (up to Week 16)
measure: Incidence of serious TEAEs through Week 16
timeFrame: From Baseline to End of initial Treatment Period (up to Week 16)
measure: Incidence of TEAEs leading to permanent discontinuation of Investigational Medicinal Product (IMP) through Week 16
timeFrame: From Baseline to End of initial Treatment Period (up to Week 16)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ps0041 20023
city: Beijing
country: China
facility: Ps0041 20247
city: Beijing
country: China
facility: Ps0041 20306
city: Guangzhou
country: China
facility: Ps0041 20117
city: Guangzhou
country: China
facility: Ps0041 20311
city: Guangzhou
country: China
facility: Ps0041 20313
city: Hangzhou
country: China
facility: Ps0041 20022
city: Hangzhou
country: China
facility: Ps0041 20193
city: Hangzhou
country: China
facility: Ps0041 20296
city: Jinan
country: China
facility: Ps0041 20312
city: Jinan
country: China
facility: Ps0041 20318
city: Ningbo
country: China
facility: Ps0041 20310
city: Shanghai
country: China
facility: Ps0041 20308
city: Shenzhen
country: China
facility: Ps0041 20184
city: Tianjin
country: China
facility: Ps0041 20136
city: Wuhan
country: China
facility: Ps0041 20120
city: Wuxi
country: China
facility: Ps0041 20314
city: Xi'an
country: China
facility: Ps0041 20309
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: