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Bored Studies
RecruitingPhase 3

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

AstraZeneca · with Amgen · NCT06883305

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
990
US sites recruiting
59
Study start
March 18, 2025
Record last updated
September 3, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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)

Being studied: Tezepelumab; Placebo

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
A Study to Investigate the Efficacy and Safety of Tezepelumab in… (NCT06883305) | Bored Studies