Recruiting NCT06878261

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Phase III Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tezepelumab, Placebo.
Who it may be relevant to: Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Bulgaria +17
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Overview

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed description

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.

Interventions

Biological Tezepelumab
Tezepelumab subcutaneous injection
Other Placebo
Placebo subcutaneous injection

Primary outcome measures

Annualised rate of moderate or severe COPD exacerbations [Time frame: Baseline up to 76 weeks]

Secondary outcome measures (12)

Change from baseline in post-BD FEV1 [Time frame: From baseline to Week 52]
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [Time frame: From baseline to Week 52]
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score [Time frame: From baseline over 52 weeks]
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit. [Time frame: Baseline up to 76 weeks]
Annualised rate of severe COPD exacerbations [Time frame: Baseline up to 76 weeks]
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation [Time frame: Baseline up to 76 Weeks]
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score [Time frame: From baseline over 52 weeks]
Change from baseline in the COPD assessment Test (CAT) total score [Time frame: From baseline over 52 weeks]
Clinical meaningful improvement in COPD Assessment Test (CAT) total score [Time frame: From baseline over 52 weeks]
Time to first moderate or severe COPD exacerbation [Time frame: Baseline up to 76 weeks]
Time to first severe COPD exacerbation [Time frame: Baseline up to 76 weeks]
Pharmacokinetics (PK): Serum trough concentrations [Time frame: Baseline, Week 24, Week 36, Week 52]

Eligibility criteria

Inclusion criteria

≥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, if triple therapy is considered not appropriate, ≥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. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
EOS ≥ 150 cells/μL during screening
CAT ≥15 at screening
Former or current smokers ≥10 pack-years

Exclusion criteria

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

Concomitant therapies:

Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications
LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment