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Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma (NOZOMI)

Primary Purpose

Severe Asthma

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Biological: Experimental: Tezepelumab

About this trial

This is an interventional treatment trial for Severe Asthma focused on measuring Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.

Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.

At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.

Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening or on day of registration.

Exclusion Criteria:

Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in the current study or previous tezepelumab studies

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tezepelumab

Arm Description

Tezepelumab: Tezepelumab subcutaneous injection

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events

The number of subjects who experienced an AE during on-treatment period was summarised.

Secondary Outcome Measures

Full Information

NCT ID

NCT04048343

First Posted

June 5, 2019

Last Updated

May 9, 2022

Sponsor

AstraZeneca

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT04048343

Brief Title

Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

Acronym

NOZOMI

Official Title

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tezepelumab in Japanese Adults and Adolescents With Inadequately Controlled Severe Asthma (NOZOMI)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 10, 2019 (Actual)

Primary Completion Date

March 18, 2021 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

Detailed Description

This is open-label, single arm study designed to evaluate the safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 66 subjects will be dosed in Japan. Subjects will receive tezepelumab administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Asthma

Keywords

Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

All subject will be dosed tezepelumab administered subcutaneously

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tezepelumab

Arm Type

Experimental

Arm Description

Tezepelumab: Tezepelumab subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Biological: Experimental: Tezepelumab

Other Intervention Name(s)

Tezepelumab

Intervention Description

Tezepelumab subcutaneous injection every 4 weeks

Primary Outcome Measure Information:

Title

Number of Subjects With Adverse Events

Description

The number of subjects who experienced an AE during on-treatment period was summarised.

Time Frame

From first dose of study drug until last study visit at Week 64

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months. Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening or on day of registration. Exclusion Criteria: Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in the current study or previous tezepelumab studies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masaharu Shinkai, MD

Organizational Affiliation

Tokyo Shinagawa Hospital Medical Corporation Association, Japan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0022

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

228-0815

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

140-8522

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

169-0073

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00019&attachmentIdentifier=97c43e3b-e498-4f8b-85d5-2faf4536e7c7&fileName=D5180c00019_CSP-v3_Redacted.pdf&versionIdentifier=

Description

Related Info

URL

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Description

CSR Synopsis

URL

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Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

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