Trials / Recruiting
RecruitingNCT05507242
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Asger Sverrild · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
Detailed description
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD on LABA+LAMA±ICS with ≥ 1 exacerbation the past 12 months. Approximately 80 subjects will be randomized to receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 20-week treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tezepelumab | Tezepelumab 210 mg for 20 weeks (5 doses in total, 4-week intervals), administered subcutaneously |
| OTHER | Placebo | Placebo subcutaneous injection for 20 weeks (5 doses in total, 4-week intervals) |
Timeline
- Start date
- 2022-10-25
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2022-08-18
- Last updated
- 2024-08-21
Locations
2 sites across 2 countries: Denmark, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05507242. Inclusion in this directory is not an endorsement.