Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2022-09-27

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

No masking is used. All involved know the identity of the intervention assignment.

Study Groups

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Tezepelumab

Tezepelumab subcutaneous injection

Group Type EXPERIMENTAL

Tezepelumab

Intervention Type BIOLOGICAL

Single dose subcutaneous injection

Interventions

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Tezepelumab

Single dose subcutaneous injection

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No