Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Condition: Moderate to Severe Asthma
MeSH terms: Influenza, Human; Asthma
Intervention: Tezepelumab; Placebo
Intervention description: 210 mg SC injection Q4W.; SC injection Q4W.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Neither the participant nor any of the investigators or sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. Since tezepelumab and placebo are not visually distinct, study intervention will be handled by a qualified person (eg, pharmacist or study nurse) at the site.
Enrollment: 70.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Tezepelumab; Humoral Immune Response; Quadrivalent Influenza Vaccination; Antibody response; Subcutaneous

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.
    

Eligibility 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.