Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    396
  • sponsor
    AstraZeneca
Updated on 17 January 2021
fluticasone
albuterol

Summary

A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma

Description

This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 subjects will be randomized regionally (China/non-China). Subjects will receive tezepelumab, or placebo, 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.

Details
Treatment Placebo, Experimental: Tezepelumab
Clinical Study IdentifierNCT03927157
SponsorAstraZeneca
Last Modified on17 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Asthma or Asthma (Pediatric) or Allergies & Asthma?
Do you have any of these conditions: Asthma or asthmatic or bronchial asthma or Asthma (Pediatric) or Allergies & Asthma?
Do you have any of these conditions: Asthma or asthmatic or Asthma (Pediatric) or bronchial asthma or Allergies & Asthma?
Do you have any of these conditions: Asthma or bronchial asthma or Asthma (Pediatric) or Allergies & Asthma or asthmatic?
Age. 18-80
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 6 months
Documented treatment with a total daily dose of either medium or high dose ICS ( 500 g 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
Morning pre-BD FEV1 <80% predicted normal
Evidence of asthma as documented by either: Documented historical reversibility of FEV1 12% and 200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 12% and 200 mL during screening
Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS
ACQ-6 score 1.5 at screening and on day of randomization

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
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