Trials / Completed
CompletedNCT03688074
Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 75 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 adults with inadequately controlled asthma.
Detailed description
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled moderate-to-severe asthma, taking inhaled corticosteroids and at least one additional asthma controller. Approximately 110 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 28-week treatment period. Although, due to the Covid-19 pandemic this may be an extended time frame for some subject visits. The study also includes a post-treatment follow-up period of 12 weeks.
Conditions
- Asthma
- Bronchial Diseases
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Immune System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tezepelumab | Tezepelumab subcutaneous injection |
| OTHER | Placebo | Placebo subcutaneous injection |
Timeline
- Start date
- 2018-11-02
- Primary completion
- 2020-11-16
- Completion
- 2020-11-16
- First posted
- 2018-09-28
- Last updated
- 2022-02-21
- Results posted
- 2022-02-21
Locations
28 sites across 5 countries: United States, Canada, Denmark, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03688074. Inclusion in this directory is not an endorsement.