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-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 16 November 2020

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.
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.
6Evidence of asthma as documented by either:
(a)Historical airway reversibility, or
(b)Airway reversibility after use of an inhaled short-acting ß2 agonist (SABA) (FEV1 = 12%) demonstrated at Visit 1a, or at Visit 2a if not achieved at Visit 1a and historical airway reversibility is not available.
7Pre bronchodilator (BD) FEV1 of = 70% of predicted normal value at Visit 1a.

Weight
11Body weight = 16 kg at Visit 1 and Visit 2 (Day 1).
12Body mass index for age at both screening and Day 1 that is between 5th and 95th percentile (Centers for Disease Control Growth Charts).
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 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 3 months of Visit 1, up to and including Visit 2 (Day 1).
3Use of systemic or intra-articular glucocorticosteroids for conditions other than asthma is not allowed within 3 months prior to Visit 2 and is discouraged until EOS.
4History of hospitalisation (overnight admission) for asthma within 6 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 3 months 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
22 Any clinical signs, symptoms, or abnormal findings during screening that may be indicative of past or present MIS-C.

Study & Design

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