Phase 2
N=337
Tezepelumab COPD Exacerbation Study
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT04039113 ↗Enrolled (actual)
337
Serious AEs
34.2%
Results posted
Feb 2025
Primary outcome: Primary: Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD. — 1.75; 2.11 exacerbations per year — p=0.1042
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tezepelumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD. |
1.75; 2.11 | 0.1042 |
| SECONDARY Time to First Moderate/Severe COPD Exacerbation |
94; 105 | — |
| SECONDARY Proportion of Participants COPD Exacerbation Free at Week 52 |
71; 63 | — |
| SECONDARY Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks |
0.13; 0.25 | — |
| SECONDARY Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks |
16; 22 | — |
| SECONDARY Time to First Severe COPD Exacerbation |
16; 22 | — |
| SECONDARY Least Square (LS) Mean Difference in Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 (FEV1) at Week 52 |
0.026; -0.029 | — |
| SECONDARY Lease Square (LS) Mean Difference in Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 |
-4.796; -1.863 | — |
| SECONDARY Proportion of Participants Achieving a Minimum Clinically Important Difference of 4 Units or More in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 |
65; 59 | — |
| SECONDARY Least Square (LS) Mean Difference in Change From Baseline in COPD Assessment Tool (CAT) Total Score at Week 52 |
-3.037; -1.182 | — |
| SECONDARY Serum Concentration of Tezepelumab |
NA; 25.881; 44.316; 49.093; 48.667; 52.659 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab |
10; 19; 5; 8; 2; 1 | — |
Summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria
- History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
- History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
- CAT score of ≥15 at enrollment and on day of randomization.
- Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.
Exclusion Criteria
- Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
- Major surgery within 8 weeks before enrollment.
- History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study
- The patient has active COVID 19 infection during screening period.
Data sourced from ClinicalTrials.gov (NCT04039113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.