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

NCT06883305 · AstraZeneca
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥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 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD 2. Asthma, incl. pediatric, or ACOS 3. Any unstable disorder that can impact participants safety or study outcomes 4. Tuberculosis requiring treatment within 12 months prior V2 5. Malignancies current or past Concomitant therapies: * Macrolides (less than 6 months) * Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
Study design
Enrollment target: 990 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-18
Estimated completion: 2029-06-05
Last updated: 2026-04-13
Interventions
Biological: TezepelumabOther: Placebo
Primary outcomes
  • Annualised rate of moderate or severe COPD exacerbations (Baseline up to 76 weeks)
Sponsor
AstraZeneca · industry
With: Amgen
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorDave Singh, MD · principal_investigator, Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
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A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) · TrialPath