Tezepelumab Exacerbation study
Research type
Research Study
Full title
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (NAVIGATOR)
IRAS ID
236195
Contact name
Andrew Menzies-Gow
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-003078-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
103031, IND Number
Duration of Study in the UK
2 years, 6 months, 15 days
Research summary
The purpose of this study is to determine if tezepelumab reduces asthma exacerbations in subjects that are uncontrolled with severe asthma who are receiving standard of care therapy. \nSubjects with severe asthma currently treated with standard of care therapy, a history of 2 or more asthma exacerbations in the previous year prior to visit 1, between the ages of 12 and 80, may be eligible to take part in this study that will last 70 weeks in duration with 3 study periods (screening/run-in, treatment and follow-up). If a subject meets the requirements for entry in the treatment period, the subject will go to the clinic for dosing of the blinded medication given via an injection under the skin There will be regular scheduled visits to the clinic to receive study medication injections, to complete questionnaires, to assess the health of the subject and to evaluate the effect of the study medication on lung function. Blood samples will be collected to measure the levels of the medication in the subject’s blood at a few time points throughout the treatment and follow-up periods. Subjects will be provided with an electronic diary to be used at home to record their symptoms related to their asthma, the use of their asthma medications and completion of other questionnaires.\n
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0725
Date of REC Opinion
4 Jul 2018
REC opinion
Further Information Favourable Opinion