Phase 3
N=133
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Chronic Plaque Psoriasis · Moderate to Severe Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT06011733 ↗Enrolled (actual)
133
Serious AEs
3.3%
Results posted
Feb 2026
Primary outcome: Primary: Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 — 3.0; 94.0 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Other); Bimekizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 |
3.0; 94.0 | <0.001 sig |
| PRIMARY Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 |
3.0; 92.0 | <0.001 sig |
| SECONDARY Percentage of Participants With PASI75 Response at Week 4 |
3.0; 74.0 | <0.001 sig |
| SECONDARY Percentage of Participants With PASI100 Response at Week 16 |
0; 65.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 |
8.0; 84.1 | — |
| SECONDARY Percentage of Participants With PSD P-SIM Response for Pain at Week 16 |
14.3; 86.1 | — |
| SECONDARY Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 |
20.0; 91.6 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 |
51.5; 62.0 | — |
| SECONDARY Percentage of Participants With Serious TEAEs Through Week 16 |
9.1; 1.0 | — |
| SECONDARY Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 |
3.0; 1.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06011733). 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.