Phase 1
Completed N=18
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Source: ClinicalTrials.gov NCT04673630 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Tezepelumab — 27.1 microgram per milliliter (mcg/mL)
Summary
This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Tezepelumab |
27.1 | — |
| PRIMARY Time to Achieve Maximum Observed Serum Concentration (Tmax) of Tezepelumab |
3.47 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time Zero to The Last Measurable Concentration (AUC0-last) of Tezepelumab |
872 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tezepelumab |
974 | — |
| PRIMARY Terminal Phase Elimination Half-Life (t1/2) of Tezepelumab |
25.7 | — |
| PRIMARY Apparent Clearance (CL/F) of Tezepelumab |
0.0802 | — |
| PRIMARY Apparent Steady-State Volume of Distribution (Vss/F) of Tezepelumab |
3.08 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Tezepelumab |
2.98 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab |
3; 2; 1; 3; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place.
- Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and Disease Characteristics
- Documented physician diagnosed asthma for at least 6 months prior to Visit 1.
- Documented treatment with total daily dose of either low, medium, or high dose ICS for at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020) with stable dose for at least 3 months prior to Visit 1.
- Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1
- Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).
Exclusion Criteria
- History of any clinically significant disease or disorder other than asthma which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day 1).
- History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1).
- History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation.
- History of systemic corticosteroid use for the maintenance treatment of asthma within 6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.
- History of cancer.
- History of hypersensitivity or anaphylactic reaction to any biologic therapy.
Data sourced from ClinicalTrials.gov (NCT04673630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.