Mild, moderate or severe asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 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 2 Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and Disease Characteristics 3 Documented 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. 4 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. 6 Inclusion criterion 6 (historical or current airway reversibility) removed with version 3.0 of Clinical Study Protocol. 7 Pre bronchodilator (BD) FEV1 of = 50% of predicted normal value at Visit 1. Weight 11 Body weight = 16 kg at Visit 1 and Visit 2 (Day 1). 12 Inclusion 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
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: Medical Conditions 1 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. 2 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). 3 Exclusion criterion 3 (previous exclusion for intra-articular glucocorticosteroids for conditions other than asthma) removed with version 3.0 of Clinical Study Protocol. 4 History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1). 5 History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation. 6 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. 11 History of cancer. Prior/Concurrent Clinical Study Experience 17 History 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. Other Exclusions 31 Participants 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. 32 Participants with a history of severe COVID-19 infection requiring hospitalisation. 33 Receipt of any COVID-19 vaccine 28 days prior to Visit 2 (Day 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) • Time to Cmax (tmax) • Area under the concentration-time curve (AUC) • Terminal phase elimination half-life (t1/2) • Apparent clearance (CL/F) • Apparent steady-state volume of distribution (Vss/F);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Presence of anti-drug antibodies (ADA);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study | — |
Countries
Hungary, South Africa, United Kingdom
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed