The Phase 3 trial evaluating bimekizumab for moderate to severe plaque psoriasis in Chinese adults reached primary completion on 2025-02-05. Results indicated that 94.0% of participants treated with bimekizumab achieved a Psoriasis Area Severity Index 90 (PASI90) response at Week 16, compared to 3.0% in the placebo group.
Background
Plaque psoriasis is a chronic inflammatory skin condition characterized by red, scaly patches. Moderate to severe forms of the condition can significantly impact a patient's quality of life. This study focused on adult participants in China.
Trial design
This completed Phase 3 study (NCT06011733) enrolled 133 adult participants in China with moderate to severe plaque psoriasis. The primary purpose was to compare the efficacy and safety of subcutaneously administered bimekizumab for 16 weeks versus placebo.
Key results
The study reported significant efficacy outcomes for bimekizumab compared to placebo at Week 16:
- Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16: 94.0% for bimekizumab (BKZ Dosage Regimen 1) versus 3.0% for placebo.
- Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16: 92.0% for bimekizumab versus 3.0% for placebo.
- Percentage of Participants With PASI100 Response at Week 16: 65.0% for bimekizumab versus 0% for placebo.
- Early response was also observed, with 74.0% of bimekizumab participants achieving PASI75 Response at Week 4, compared to 3.0% for placebo.
Statistical analyses further supported these findings:
- For PASI90 response, the odds ratio (OR) was 501.333 (95.0% CI: 58.125, 4324.033) with a p-value of 0.001.
- For IGA 0/1 response, the OR was 368.0 (95.0% CI: 44.286, 3057.94) with a p-value of 0.001.
- For PASI75 response at Week 4, the OR was 91.077 (95.0% CI: 11.844, 700.362) with a p-value of 0.001.
- For PASI100 response, the Fisher Exact p-value was 0.001.
Patient-reported outcomes also showed improvement:
- Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16: 84.1% for bimekizumab versus 8.0% for placebo.
- Percentage of Participants With PSD P-SIM Response for Pain at Week 16: 86.1% for bimekizumab versus 14.3% for placebo.
What this means
The results from this Phase 3 trial suggest that bimekizumab demonstrates high efficacy in treating moderate to severe plaque psoriasis in Chinese adult participants. The substantial differences in PASI90, IGA 0/1, and PASI100 response rates, along with significant improvements in patient-reported symptoms like itch and pain, indicate a strong potential benefit for this patient population. The rapid onset of action, as shown by the PASI75 response at Week 4, could also be a clinically meaningful advantage.
Source
The information regarding the primary completion and results of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06011733, titled "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis," were posted on 2025-02-05 on clinicaltrials.gov.