Trial results for a bioequivalence study (NCT05292131) investigating bimekizumab administered via different autoinjector presentations were posted on ClinicalTrials.gov on 2025-04-10. The study in healthy participants aimed to compare the pharmacokinetics, safety, and tolerability of a 1x2mL versus a 2x1mL subcutaneous injection. Key analyses showed geometric mean ratios for pharmacokinetic parameters were approximately 97.5% (90.0% CI: 90.2 to 105.4), indicating similar systemic exposure between the two formulations.
Background
The study aimed to compare the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous dose of bimekizumab when administered using a bimekizumab-autoinjector (AI)-2mL presentation versus a bimekizumab-AI-2x1mL presentation in healthy study participants. This type of study is crucial for ensuring that different formulations or delivery methods of a drug provide comparable systemic exposure.
Trial design
The study (NCT05292131) was a Phase 1, randomized, open-label, parallel-group bioequivalence study that enrolled 121 healthy study participants. Participants received a single subcutaneous dose of bimekizumab using either the bimekizumab-autoinjector (AI)-2mL presentation or the bimekizumab-AI-2x1mL presentation. The study assessed pharmacokinetics, safety, and tolerability.
Key results
The trial evaluated the pharmacokinetics and safety of bimekizumab across the two autoinjector presentations. Key pharmacokinetic parameters included:
- "Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC)": The geometric least squares mean was 1223 days*micrograms/milliliter (days*ug/mL) for the Bimekizumab-AI-2mL (Test) group and 1255 days*micrograms/milliliter (days*ug/mL) for the Bimekizumab-AI-2x1mL (Reference) group.
- "Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t)": The geometric least squares mean was 1186 day*ug/mL for the Bimekizumab-AI-2mL (Test) group and 1223 day*ug/mL for the Bimekizumab-AI-2x1mL (Reference) group.
- "Maximum Plasma Concentration (Cmax)": The geometric least squares mean was 35.17 micrograms/milliliter (ug/mL) for the Bimekizumab-AI-2mL (Test) group and 36.55 micrograms/milliliter (ug/mL) for the Bimekizumab-AI-2x1mL (Reference) group.
- "Apparent Terminal Half-life (t1/2)": The geometric least squares mean was 24.65 days for the Bimekizumab-AI-2mL (Test) group and 24.38 days for the Bimekizumab-AI-2x1mL (Reference) group.
Analyses comparing the two formulations demonstrated bioequivalence:
- The Geometric Mean Ratio (percentage [%]) for a key pharmacokinetic parameter was 97.5% (90.0% CI: 90.2 to 105.4).
- Another Geometric Mean Ratio (%) was 97.05% (90.0% CI: 90.1 to 104.55).
- A third Geometric Mean Ratio (%) was 96.21% (90.0% CI: 88.6 to 104.47).
- A fourth Geometric Mean Ratio (%) was 101.13% (90.0% CI: 94.18 to 108.59).
Regarding safety, the "Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up" was 43.3% for the Bimekizumab-AI-2mL (Test) group and 49.2% for the Bimekizumab-AI-2x1mL (Reference) group. No "Treatment-emergent Serious Adverse Event (SAE)" was reported in either group, with both showing 0% of participants experiencing such events.
What this means
The results of this bioequivalence study indicate that the bimekizumab-autoinjector (AI)-2mL and bimekizumab-AI-2x1mL presentations provide comparable systemic exposure of bimekizumab in healthy individuals. The geometric mean ratios for key pharmacokinetic parameters, with their 90% confidence intervals falling within standard bioequivalence criteria, support the interchangeability of these two autoinjector formulations. Additionally, the safety profiles were similar between the two groups, with no serious adverse events reported in either arm. These findings are important for the flexible administration and patient convenience of bimekizumab.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05292131, titled "A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants," were posted on 2025-04-10 on clinicaltrials.gov.