A study to evaluate how the body processes the drug tezepelumab (pharmacokinetics) in children 5 to 11 Years of age with asthma

Phase 1

• Conditions: Mild, moderate or severe asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000554-97-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1Written 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
2Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1).

Type of Subject and Disease Characteristics
3Documented physician diagnosed asthma for at least 6 months prior to Visit 1. If the subject is naïve to the study site, the participant/guardian must self-report a physician diagnosis of asthma and the investigator must confirm by review of medical history with the participant/guardian.
4Documented 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.
6Inclusion criterion 6 (historical or current airway reversibility) removed with version 3.0 of Clinical Study Protocol.
7Pre bronchodilator (BD) FEV1 of = 50% of predicted normal value at Visit 1.

Weight
11Body weight = 16 kg at Visit 1 and Visit 2 (Day 1).
12Inclusion criterion 12 (Body mass index for age percentiles) removed with version 4.0 of Clinical Study Protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:
Medical Conditions
1History 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.
2History 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).
3Exclusion criterion 3 (previous exclusion for intra-articular glucocorticosteroids for conditions other than asthma) removed with version 3.0 of Clinical Study Protocol.
4History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1).
5History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation.
6History 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.
11History of cancer.

Prior/Concurrent Clinical Study Experience
17History of hypersensitivity or anaphylactic reaction to any biologic therapy.

Diagnostic assessments
22Any clinical signs, symptoms, or abnormal findings during screening that may be indicative of past or present MIS-C.

Other Exclusions
31Participants who have had a confirmed COVID-19 infection and have not fully recovered (based on Investigator judgement) for at least 8 weeks prior to Visit 1.
32Participants with a history of severe COVID-19 infection requiring hospitalisation.
33Receipt of any COVID-19 vaccine 28 days prior to Visit 2 (Day 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the pharmacokinetic parameters following a single subcutaneous administration of tezepelumab in children with mild, moderate, or severe asthma;Secondary Objective: • To evaluate the immunogenicity of tezepelumab;Primary end point(s): •Maximum concentration (Cmax)<br>•Time to Cmax (tmax) <br>•Area under the concentration-time curve (AUC)<br>•Terminal phase elimination half-life (t1/2)<br>•Apparent clearance (CL/F)<br>•Apparent steady-state volume of distribution (Vss/F);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Presence of anti-drug antibodies (ADA);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study