Last updated 10 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

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.

StudyEMBARK

SponsorAstraZeneca

Study typeInterventional

Conditions

Moderate/severe copd

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06883305