Phase 3
Completed N=47
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
Source: ClinicalTrials.gov NCT05020249 ↗
Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Mar 2024
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
5citations · ~3 / year
Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.
Summary
The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.
Linked Publications
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Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT05020249) and the linked publication. 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. Informational only — not medical advice.