Trial results for bimekizumab in Chinese adults with moderate to severe plaque psoriasis were posted on ClinicalTrials.gov on 2026-02-20. The study showed that 94.0% of participants treated with bimekizumab achieved a Psoriasis Area Severity Index 90 (PASI90) response at Week 16, compared to 3.0% for those on placebo. This represents a significant improvement in skin clearance.
Background
The trial evaluated bimekizumab for the treatment of moderate to severe plaque psoriasis in Chinese adult study participants. Plaque psoriasis is a chronic inflammatory skin condition characterized by red, scaly patches.
Trial design
The study (NCT06011733) was a Phase 3, placebo-controlled trial that enrolled 133 Chinese adult participants with moderate to severe plaque psoriasis. The primary purpose of this study was to compare the efficacy and safety of bimekizumab administered subcutaneously for 16 weeks versus placebo in this population. Participants were randomized to receive either bimekizumab (BKZ Dosage Regimen 1) or placebo.
Key results
The trial results demonstrated significant efficacy for bimekizumab compared to placebo across multiple endpoints.
- At Week 16, 94.0% of participants in the bimekizumab group achieved a Psoriasis Area Severity Index 90 (PASI90) response, compared to 3.0% in the placebo group. A Cochran-Mantel-Haenszel analysis showed an Odds Ratio (OR) of 501.333 (95.0% CI: 58.125 to 4324.033, p-value 0.001).
- Also at Week 16, 92.0% of bimekizumab-treated participants achieved an Investigator´s Global Assessment (IGA) 0/1 response, versus 3.0% for placebo. The Cochran-Mantel-Haenszel analysis yielded an OR of 368.0 (95.0% CI: 44.286 to 3057.94, p-value 0.001).
- Early response was observed with 74.0% of bimekizumab participants achieving a PASI75 response at Week 4, compared to 3.0% for placebo. The Cochran-Mantel-Haenszel analysis showed an OR of 91.077 (95.0% CI: 11.844 to 700.362, p-value 0.001).
- Complete skin clearance (PASI100 response) at Week 16 was achieved by 65.0% of the bimekizumab group, while 0% of the placebo group achieved this. A Fisher Exact analysis showed a p-value of 0.001.
- Patient-reported outcomes also showed significant improvements: 84.1% of bimekizumab participants reported a Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16, compared to 8.0% for placebo.
- Similarly, 86.1% of bimekizumab participants reported a P-SIM response for pain at Week 16, compared to 14.3% for placebo.
What this means
The results from this Phase 3 trial indicate that bimekizumab demonstrated high efficacy in achieving significant skin clearance and reducing symptoms like itch and pain in Chinese adults with moderate to severe plaque psoriasis. The substantial differences observed across key endpoints such as PASI90, IGA 0/1, and PASI100 responses, as well as patient-reported outcomes for itch and pain, suggest that bimekizumab could be a highly effective treatment option for this population. These findings contribute to the understanding of bimekizumab's potential in diverse patient groups.
Source
The information regarding these trial results 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 2026-02-20 on clinicaltrials.gov.