Trials / Recruiting
RecruitingNCT06878261
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 990 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tezepelumab | Tezepelumab subcutaneous injection |
| OTHER | Placebo | Placebo subcutaneous injection |
Timeline
- Start date
- 2025-03-25
- Primary completion
- 2029-03-13
- Completion
- 2029-06-05
- First posted
- 2025-03-14
- Last updated
- 2026-04-13
Locations
268 sites across 22 countries: United States, Argentina, Australia, Belgium, Bulgaria, Colombia, Denmark, France, Greece, Hong Kong, Hungary, Israel, Japan, Netherlands, New Zealand, Peru, Romania, South Africa, Sweden, Thailand, Turkey (Türkiye), Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06878261. Inclusion in this directory is not an endorsement.