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A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

NCT06878261

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Tezepelumab, Placebo

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Colombia, Denmark, France

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 overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (268)
  • Cullman, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Inglewood, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Redding, California, United States
  • San Diego, California, United States
  • New Britain, Connecticut, United States
  • Wilmington, Delaware, United States
  • Bay Pines, Florida, United States
  • Boynton Beach, Florida, United States
  • Clearwater, Florida, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Leesburg, Florida, United States
  • Margate, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocala, Florida, United States
  • Palmetto Bay, Florida, United States
  • Winter Park, Florida, United States
  • Adairsville, Georgia, United States
  • Atlanta, Georgia, United States
  • Cordele, Georgia, United States
  • Decatur, Georgia, United States
  • Fort Eisenhower, Georgia, United States
  • Savannah, Georgia, United States
  • Evanston, Illinois, United States
  • + 238 more on CT.gov