A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
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).
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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 ≥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
- 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
- Macrolides (less than 6 months)
- Systemic immuno-suppressive, -modulating medications
- LTOT >4.0 L/min or O2 saturation <89% despite LTOT
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06878261
Intervention or treatment
BIOLOGICAL: Tezepelumab
OTHER: Placebo
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
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Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
Coffs Harbour, Australia
Research Site
Frankston, Australia
Research Site
Garran, Australia
Research Site
Nedlands, Australia
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Who is running the clinical trial?
AstraZeneca
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose 1 of Tezepelumab
| Biological: Tezepelumab |
EXPERIMENTAL: Dose 2 of Tezepelumab
| Biological: Tezepelumab |
PLACEBO_COMPARATOR: Matching Placebo
| Other: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Annualised rate of moderate or severe COPD exacerbations | The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo. | Baseline up to 76 weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) | Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration | From baseline to Week 52 |
| Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score | Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status. | From baseline over 52 weeks |
| Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL. | The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL | Baseline up to 76 weeks |
| Annualised rate of severe COPD exacerbations | The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo | Baseline up to 76 weeks |
| Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score | Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status. | From baseline over 52 weeks |
| Change from baseline in the COPD assessment Test (CAT) total score | Change from baseline in the CAT total score over 52 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status. | From baseline over 52 weeks |
| Clinical meaningful improvement in COPD Assessment Test (CAT) total score | Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks. CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status. | From baseline over 52 weeks |
| Time to first moderate to severe COPD exacerbation | Time to first occurrence of moderate to severe COPD exacerbation up to 76 weeks | Baseline up to 76 weeks |
| Time to first severe COPD exacerbation | Time to first occurrence of severe COPD exacerbation up to 76 weeks | Baseline up to 76 weeks |
| Change from baseline in post-BD FEV1 | Change from baseline in post-BD FEV1 at Week 52 | From baseline to Week 52 |
| Pharmacokinetics (PK): Serum trough concentrations | Serum trough concentrations | Baseline, Week 24, Week 36, Week 52 |
| Immunogenicity of anti-drug antibodies (ADA) | Incidence of anti-drug antibodies | Baseline to Week 52 |
References
Clinical Trials Gov: A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)Other trials to consider
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