Study to assess the effect of tezepelumab on the immune response to influenza vaccination in participants with asthma

Phase 1

• Conditions: Moderate to 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: EUCTR2022-003286-37-Outside-EU/EEA
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-22
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
- Morning pre-bronchodilator FEV1 (Forced expiratory volume) of > 50% predicted normal value at Visit 1 or Visit 2.
- Body weight = 40 kg.
- For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
- Must have 'not well-controlled' asthma.
Are the trial subjects under 18? yes
Number of subjects for this age range: 43
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Clinically important pulmonary disease other than asthma.
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
- Life-threatening asthma.
- History of cancer.
- Allergy to eggs, if egg based influenza vaccine will be administered.
- History of anaphylaxis to any biologic therapy.
- Current smokers or participants with smoking history = 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
- History of alcohol or drug abuse within 12 months prior to the date of informed consent.
- Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.

Study & Design

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