Status:
COMPLETED
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04673630
Start Date
February 23 2021
End Date
September 27 2022
Last Update
January 8 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Budapest, Hungary, 1094
2
Research Site
Cape Town, South Africa, 7700
3
Research Site
Bristol, United Kingdom, BS2 8BJ
4
Research Site
Glasgow, United Kingdom, G51 4TF