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A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorAstraZeneca

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tezepelumab

    Biological/Vaccine

    Tezepelumab subcutaneous injection

  • Placebo

    Other intervention

    Placebo subcutaneous injection

Treatment groups

990 Participants
are divided into 3 treatment groups
Group A: Dose 1 of TezepelumabExperimental treatment 1 intervention
Group B: Dose 2 of TezepelumabExperimental treatment 1 intervention
Group C: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annualised rate of moderate or severe COPD exacerbations

The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

Time frame
Baseline up to 76 weeks

Secondary outcomes

1

Change from baseline in post-BD FEV1

Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration

Time frame
From baseline to Week 52
2

Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Time frame
From baseline to Week 52
3

Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score

Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.

Time frame
From baseline over 52 weeks
4

Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.

The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit.

Time frame
Baseline up to 76 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Amgen

Collaborator

Source ClinicalTrials.gov
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