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

NCT ID: NCT05062759

Last Updated: 2023-06-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2022-07-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Moderate to Severe Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Tezepelumab

Participants will be randomized to receive tezepelumab 210 mg administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Group Type EXPERIMENTAL

Tezepelumab

Intervention Type DRUG

210 mg SC injection Q4W.

Placebo to Tezepelumab

Participants will be randomized to receive placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC injection Q4W.

Interventions

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Tezepelumab

210 mg SC injection Q4W.

Intervention Type DRUG

Placebo

SC injection Q4W.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Bakersfield, California, United States

Site Status

Research Site

Huntington Beach, California, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Columbia, Missouri, United States

Site Status

Research Site

Northfield, New Jersey, United States

Site Status

Research Site

Dayton, Ohio, United States

Site Status

Research Site

Toledo, Ohio, United States

Site Status

Research Site

Edmond, Oklahoma, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Tyler, Texas, United States

Site Status

Research Site

Waco, Texas, United States

Site Status

Research Site

Salt Lake City, Utah, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Cole J, Capala-Szczurko I, Roseti S, Chen C, Caveney S, Aksyuk AA, Streicher K, Ponnarambil S, Colice G. Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study. Pulm Ther. 2024 Mar;10(1):53-67. doi: 10.1007/s41030-023-00245-9. Epub 2023 Dec 8.

Reference Type DERIVED
PMID: 38064153 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00031&amp;attachmentIdentifier=30f0d69f-126e-4f79-8bc8-0542f713c2b0&amp;fileName=D5180C00031_CSR_Synopsis_Redacted.pdf&amp;versionIdentifier=

CSR Synopsis\_Redacted

Other Identifiers

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D5180C00031

Identifier Type: -

Identifier Source: org_study_id

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