A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate… (NCT06878261) | Clinical Trial Compass
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
United States990 participantsStarted 2025-03-25
Plain-language summary
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)
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Annualised rate of moderate or severe COPD exacerbations