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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05062759
Other study ID # D5180C00031
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 23, 2021
Est. completion date July 18, 2022

Study information

Verified date June 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants with moderate to severe asthma will enter the screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized participants are between the ages of 12 to 17 years. Participants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention. Serum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination) and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is expected to be fully developed. The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 18, 2022
Est. primary completion date March 21, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 21 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tezepelumab
210 mg SC injection Q4W.
Placebo
SC injection Q4W.

Locations

Country Name City State
United States Research Site Bakersfield California
United States Research Site Columbia Missouri
United States Research Site Dallas Texas
United States Research Site Dayton Ohio
United States Research Site Edmond Oklahoma
United States Research Site Huntington Beach California
United States Research Site Miami Florida
United States Research Site Milwaukee Wisconsin
United States Research Site Northfield New Jersey
United States Research Site Oklahoma City Oklahoma
United States Research Site Salt Lake City Utah
United States Research Site San Antonio Texas
United States Research Site Toledo Ohio
United States Research Site Tyler Texas
United States Research Site Waco Texas

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
From Week 12 to Week 16
Primary Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. From Week 12 to Week 16
Primary Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Week 16
Primary Post-vaccination Strain-specific Serum MN Antibody GMTs Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Week 16
Primary Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a = 4-fold Rise in HAI Antibody Titer Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Week 16
Primary Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a = 4-fold Rise in MN Antibody Titer Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
Week 16
Primary Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer = 40 Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Week 16
Primary Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer = 40 Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Week 16
Secondary Serum Tezepelumab Concentrations Tezepelumab serum concentrations were summarized using descriptive statistics at each visit. Week 0, Week 12, Week 16 and Week 28
Secondary Immunogenicity Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with =16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. From Baseline to Week 28
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