Trial results for a Phase 2 study evaluating the pharmacokinetics of bimekizumab in adolescent participants with moderate to severe plaque psoriasis were posted on ClinicalTrials.gov on 2026-05-18. The study assessed two doses, with the higher dose consistently demonstrating greater plasma concentrations over 16 weeks.
Background
The study investigated bimekizumab, an intervention for moderate to severe plaque psoriasis. This trial focused specifically on its pharmacokinetic profile in an adolescent population, an important step in understanding its potential use in younger patients.
Trial design
The Phase 2 study (NCT04718896) enrolled 41 participants with moderate to severe plaque psoriasis. The primary purpose was to assess the pharmacokinetics of bimekizumab administered subcutaneously in adolescents. The study evaluated two dose regimens: BKZ Dose A (320/160 mg) and BKZ Dose B (64/32 mg).
Key results
The trial reported plasma concentrations of bimekizumab for both dose groups:
- At Week 1, the geometric mean plasma concentration for BKZ Dose A (320/160 mg) was 21.145 µg/mL (Geometric Coefficient of Variation: 33.510), compared to 3.811 µg/mL (Geometric Coefficient of Variation: 30.424) for BKZ Dose B (64/32 mg).
- At Week 4, the geometric mean for BKZ Dose A was 11.718 µg/mL (Geometric Coefficient of Variation: 35.259), versus 1.986 µg/mL (Geometric Coefficient of Variation: 22.888) for BKZ Dose B.
- At Week 8, BKZ Dose A showed a geometric mean of 16.344 µg/mL (Geometric Coefficient of Variation: 39.386), while BKZ Dose B was 2.562 µg/mL (Geometric Coefficient of Variation: 91.934).
- At Week 12, the geometric mean for BKZ Dose A was 19.312 µg/mL (Geometric Coefficient of Variation: 38.235), and for BKZ Dose B it was 2.600 µg/mL (Geometric Coefficient of Variation: 89.916).
- At Week 16, BKZ Dose A had a geometric mean of 20.163 µg/mL (Geometric Coefficient of Variation: 41.323), compared to 2.560 µg/mL (Geometric Coefficient of Variation: 99.017) for BKZ Dose B.
What this means
The pharmacokinetic data from this Phase 2 study provides valuable insights into how bimekizumab is absorbed and distributed in adolescent patients with moderate to severe plaque psoriasis. The results clearly indicate a dose-dependent exposure, with the higher BKZ Dose A (320/160 mg) consistently achieving substantially greater plasma concentrations compared to BKZ Dose B (64/32 mg) across all measured time points from Week 1 to Week 16. This information is crucial for guiding future dose selection and understanding the systemic exposure of bimekizumab in this specific patient population, supporting further clinical development for adolescent indications.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04718896, titled "A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis", were posted on 2026-05-18 on clinicaltrials.gov.