Phase 3 N=47 Randomized Quadruple-blind Treatment

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

Moderate to Severe Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05020249 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Mar 2024

Primary outcome: Primary: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 — 0; 81.3 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: bimekizumab (Drug); Placebo (Other)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: UCB Biopharma SRL
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	0; 81.3	<0.001 sig
PRIMARY 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	0; 87.5	<0.001 sig
SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16	0; 21.9	0.080
SECONDARY Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16	0; 21.9	0.080
SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4	0; 75.0	<0.001 sig
SECONDARY Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16	0; 57.7	<0.001 sig
SECONDARY Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16	0; 62.5	<0.001 sig
SECONDARY Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16	0; 64.3	<0.001 sig
SECONDARY 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	7.1; 86.2	<0.001 sig
SECONDARY Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16	6.7; 46.9	0.007 sig
SECONDARY Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16	-3.028; -83.472	<0.001 sig
SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study	40.0; 50.0	—
SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study	6.7; 0	—
SECONDARY Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study	0; 0	—
SECONDARY Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16	-2.1; -2.4	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05020249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.