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

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Biological: Tezepelumab; Other: Placebo

• Registration Number: NCT06878261
• Lead Sponsor: AstraZeneca

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 Pulmonary Disease (COPD)

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 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.

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-14
• Study Start: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2029-03-13
• Study Completion: 2029-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 990

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 ≥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
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 of Tezepelumab	Tezepelumab	Tezepelumab, SC, Q4W
Dose 2 of Tezepelumab	Tezepelumab	Tezepelumab, SC, Q4W
Matching Placebo	Placebo	Matching placebo, SC, Q4W

Primary Outcome Measures

Name	Time	Method
Annualised rate of moderate or severe COPD exacerbations	Baseline up to 76 weeks	The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the COPD assessment Test (CAT) total score	From baseline over 52 weeks	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.
Clinical meaningful improvement in COPD Assessment Test (CAT) total score	From baseline over 52 weeks	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.
Time to first moderate to severe COPD exacerbation	Baseline up to 76 weeks	Time to first occurrence of moderate to severe COPD exacerbation up to 76 weeks
Time to first severe COPD exacerbation	Baseline up to 76 weeks	Time to first occurrence of severe COPD exacerbation up to 76 weeks
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)	From baseline to Week 52	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
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL.	Baseline up to 76 weeks	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
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score	From baseline over 52 weeks	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.
Annualised rate of severe COPD exacerbations	Baseline up to 76 weeks	The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score	From baseline over 52 weeks	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.
Change from baseline in post-BD FEV1	From baseline to Week 52	Change from baseline in post-BD FEV1 at Week 52
Pharmacokinetics (PK): Serum trough concentrations	Baseline, Week 24, Week 36, Week 52	Serum trough concentrations
Immunogenicity of anti-drug antibodies (ADA)	Baseline to Week 52	Incidence of anti-drug antibodies

Trial Locations

Locations (1)

Research Site; 🇻🇳 Hue, Vietnam