Status:
RECRUITING
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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...
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 obs...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2029
Estimated Enrollment :
990 Patients enrolled
Trial Details
Trial ID
NCT06883305
Start Date
March 18 2025
End Date
June 5 2029
Last Update
December 17 2025
Active Locations (295)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Foley, Alabama, United States, 36535
2
Research Site
Mobile, Alabama, United States, 36609
3
Research Site
Sheffield, Alabama, United States, 35660
4
Research Site
Phoenix, Arizona, United States, 85012