Trial results for a Phase 1 study (NCT04255862) evaluating the bioequivalence of bimekizumab when administered via different subcutaneous injection presentations were posted on ClinicalTrials.gov on 2025-04-10. The study in healthy participants found that pharmacokinetic parameters, such as Area Under the Curve (AUC) and Maximum Plasma Concentration (Cmax), were similar across the tested formulations, with geometric mean ratios consistently near 100%.
Background
Bimekizumab is the drug being evaluated in this study. This particular trial focused on its pharmacokinetic properties in healthy individuals rather than its therapeutic effects for a specific condition.
Trial design
The study (NCT04255862) was a Phase 1 trial designed to compare the pharmacokinetics of bimekizumab when administered subcutaneously as 1x2 mL versus 2x1 mL injections. It evaluated both a bimekizumab-safety syringe presentation and a bimekizumab-auto-injector presentation in healthy study participants. A total of 71 participants were enrolled in this terminated study.
Key results
The study evaluated the bioequivalence of different bimekizumab subcutaneous injection presentations. Key pharmacokinetic parameters, Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) and Maximum Plasma Concentration (Cmax), were measured.
- For AUC from time zero to infinity (AUC):
- Bimekizumab-SS-2mL (Test 1) had a geometric mean of 1665 days*micrograms/milliliter (days*ug/mL) (Geometric Coefficient of Variation: 34.2).
- Bimekizumab-SS-2x1mL (Reference 1) had a geometric mean of 1610 days*micrograms/milliliter (days*ug/mL) (Geometric Coefficient of Variation: 31.3).
- Bimekizumab-AI-2mL (Test 2) had a geometric mean of 1560 days*micrograms/milliliter (days*ug/mL) (Geometric Coefficient of Variation: 19.1).
- Bimekizumab-AI-2x1mL (Reference 2) had a geometric mean of 1357 days*micrograms/milliliter (days*ug/mL) (Geometric Coefficient of Variation: 35.5).
- For Maximum Plasma Concentration (Cmax):
- Bimekizumab-SS-2mL (Test 1) had a geometric mean of 43.56 ug/mL (Geometric Coefficient of Variation: 26.8).
- Bimekizumab-SS-2x1mL (Reference 1) had a geometric mean of 41.90 ug/mL (Geometric Coefficient of Variation: 23.9).
- Bimekizumab-AI-2mL (Test 2) had a geometric mean of 42.23 ug/mL (Geometric Coefficient of Variation: 20.3).
- Bimekizumab-AI-2x1mL (Reference 2) had a geometric mean of 36.94 ug/mL (Geometric Coefficient of Variation: 28.2).
Key analyses of geometric mean ratios for bioequivalence included:
- Geometric Mean Ratio for AUC (Test 1 vs Reference 1): 103.4 (90.0% CI: 86.4 to 123.8).
- Geometric Mean Ratio for AUC (Test 2 vs Reference 2): 115.0 (90.0% CI: 97.9 to 135.0).
- Geometric Mean Ratio for AUC0-t (Test 1 vs Reference 1): 102.8 (90.0% CI: 87.0 to 121.5).
- Geometric Mean Ratio for AUC0-t (Test 2 vs Reference 2): 113.4 (90.0% CI: 97.4 to 131.9).
- Geometric Mean Ratio for Cmax (Test 1 vs Reference 1): 104.0 (90.0% CI: 90.3 to 119.7).
- Geometric Mean Ratio for Cmax (Test 2 vs Reference 2): 114.3 (90.0% CI: 99.5 to 131.4).
What this means
The results of this Phase 1 bioequivalence study indicate that the different subcutaneous injection presentations of bimekizumab — specifically, 1x2 mL versus 2x1 mL doses using either a safety syringe or an auto-injector — demonstrate similar pharmacokinetic profiles in healthy individuals. The geometric mean ratios for AUC and Cmax, with their respective 90% confidence intervals, suggest that these formulations are bioequivalent. This finding supports flexibility in the administration of bimekizumab, potentially offering options for patients and healthcare providers regarding injection devices and volumes without significantly altering drug exposure.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04255862, titled "A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants," were posted on 2025-04-10 on clinicaltrials.gov.