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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03688074
Other study ID # D5180C00013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2, 2018
Est. completion date November 16, 2020

Study information

Verified date February 2022
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.


Description:

This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled moderate-to-severe asthma, taking inhaled corticosteroids and at least one additional asthma controller. Approximately 110 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 28-week treatment period. Although, due to the Covid-19 pandemic this may be an extended time frame for some subject visits. The study also includes a post-treatment follow-up period of 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date November 16, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Principal Inclusion Criteria: - Subject must be 18 to 75 years of age. - 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; must be stable for at least 3 months prior to screening visit. - 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. - At enrolment, the subject must have a predicted normal value for the morning pre-bronchodilator FEV1>50% and more than 1L. - Evidence of asthma as documented by reversibility of FEV1 =12% and =200 mL in the previous 12 months prior to screening, or during the screening period prior to randomization. - ACQ-6 score = 1.5 during the screening period prior to randomization. Principal Exclusion Criteria: - Any clinically important pulmonary disease other than asthma. - History of cancer. - Hospitalization or required OCS for asthma exacerbation within 6 weeks of enrolment or >3 exacerbations requiring OCS or hospitalization in the year prior to visit 1 or who had been intubated or admitted to ICU for asthma exacerbation in the year prior to enrolment. - History of a clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalized <2 weeks before visit 1 or during the run-in period. - Current smokers or subjects with smoking history =10 pack-yrs, including e-cigarettes. Former smokers with a smoking history of <10 pack-yrs must have stopped for at least 6 months prior to visit 1, including e-cigarette use. - History of chronic alcohol or drug abuse within 12 months prior to visit 1. - Tuberculosis requiring treatment within 12 months prior to visit 1. - History of known immunodeficiency disorder including a positive HIV test at visit 1, or the subject is taking antiretroviral medications as determined by medical history and/or subject's verbal report. - History of anaphylaxis or documented immune complex disease (type III hypersensitivity reactions) following any biologic therapy Subject randomized in a previous Tezepelumab study or in a current study with another investigational product. - Pregnant, breastfeeding or lactating women.

Study Design


Intervention

Biological:
Tezepelumab
Tezepelumab subcutaneous injection
Other:
Placebo
Placebo subcutaneous injection

Locations

Country Name City State
Canada Research Site Calgary Alberta
Canada Research Site Hamilton Ontario
Canada Research Site Montreal Quebec
Canada Research Site Ottawa Ontario
Canada Research Site Quebec
Canada Research Site Vancouver British Columbia
Denmark Research Site Aarhus N
Denmark Research Site Ålborg
Denmark Research Site Hvidovre
Denmark Research Site København NV
Denmark Research Site Naestved
Denmark Research Site Odense C
Denmark Research Site Vejle
Germany Research Site Frankfurt
Germany Research Site Frankfurt/Main
Germany Research Site Grosshansdorf
Germany Research Site Landsberg
United Kingdom Research Site Cambridge
United Kingdom Research Site Headington
United Kingdom Research Site Leicester
United Kingdom Research Site London
United Kingdom Research Site Nottingham
United Kingdom Research Site Wythenshawe
United States Research Site Boston Massachusetts
United States Research Site Denver Colorado
United States Research Site Galveston Texas
United States Research Site New Haven Connecticut
United States Research Site Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Amgen

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT. The change from baseline to end of treatment (EOT) expressed as a ratio i.e. (EOT/baseline) in numbers of each of the airway submucosal inflammatory cells, determined by microscopic evaluation of bronchoscopic biopsies. First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
Secondary Reticular Basement Membrane (RBM) Thickness Ratio Change From Baseline to EOT. The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies. First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
Secondary Percent (%) Airway Epithelial Integrity Ratio Change From Baseline to EOT. The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies. First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
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