Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

• Status: Recruiting
• Trial end date: 2022-06-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous [SC] every 4 weeks [Q4W]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Amgen

Criteria

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.

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.