Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children ≥ 5 to 11 Years of Age With Mild, Moderate, or Severe Asthma (TRAILHEAD)

Conditions
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Asthma

Intervention / Treatment
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* Biological: Tezepelumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tezepelumab<br>Tezepelumab subcutaneous injection | Biological: Tezepelumab<br>* Single dose subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 
| Time to reach Cmax (tmax) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 
| Area under the concentration-time curve (AUC) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 
| Terminal phase elimination half-life (t1/2) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 
| Apparent clearance (CL/F) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 
| Apparent steady-state volume of distribution (Vss/F) | To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma. | Baseline Day 1 and on Days 3, 7, 11, 15, 29, 57 and 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of subjects in the study that tested positive for anti-drug antibodies (ADA) to Tezepelumab | To evaluate the immunogenicity of tezepelumab. | Baseline Day 1 and on Days 29 and 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild asthma, Moderate asthma, Severe asthma