Last updated 46 days ago
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD
990 patients around the world
Available in Chile, Brazil, Mexico
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel
group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to
very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance
therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12
months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of
two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76
weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up
period of 12 weeks.
AstraZeneca
16Research sites
990Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Moderate/severe copd
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- ≥40 to ≤80 years old.COPD diagnosis ≥1 year.Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening.Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1.≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids.EOS ≥ 150 cells/μL during screening.CAT ≥15 at screening.Former or current smokers ≥10 pack-years.
- Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD.Asthma, incl. pediatric, or ACOS.Any unstable disorder that can impact participants safety or study outcomes.Tuberculosis requiring treatment within 12 months prior V2.Malignancies current or past.Macrolides (less than 6 months).Systemic immuno-suppressive, -modulating medications.LTOT >4.0 L/min or O2 saturation <89% despite LTOT.
Sites
Hospital De Base de São José do Rio Preto - CIP São José
Recruiting
Hospital Universitário São Francisco na Providência de Deus (HUSF)
Recruiting
CETI - Centro de Estudos em Terapias Inovadoras
Recruiting
Insight Centro de Pesquisas
Recruiting
INSCER - Instituto do Cérebro da PUC-RS
Recruiting
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Recruiting
Hospital de Clínicas de Porto Alegre
Recruiting
Supera Centro de Oncologia e Mastologia
Recruiting
Instituto Atena de Pesquisa - Mossoró
Recruiting
L2IP Instituto de Pesquisas Clínicas - Brasilia
Recruiting
StudyEMBARK
SponsorAstraZeneca
Study typeInterventional
Conditions
Moderate/severe copd
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06883305
