Trials / Withdrawn
WithdrawnNCT03989635
Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma.
Randomized, Subject and Investigator Blinded, Placebo-controlled Study to Demonstrate the Anti-inflammatory Effect of Fevipiprant (QAW039) in Moderate to Severe Asthma Patients With High Sputum and Blood Eosinophils.
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48 moderate to severe asthma patients with sputum and blood eosinophilia.
Detailed description
The main purpose of this study is to demonstrate the anti-inflammatory effects of fevipiprant (QAW039) compared to placebo after 12 weeks of treatment in moderate to severe asthma patients with an elevated sputum eosinophil count (≥ 2%) and high blood eosinophil count (≥ 250 cells/μL). This study is also designed to investigate the effects of fevipiprant on key inflammatory cells bearing the DP2 receptor (such as eosinophils, Th2/Tc2 cells, and ILC2 cells) in sputum and blood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QAW039 | QAW039 450mg |
Timeline
- Start date
- 2019-10-15
- Primary completion
- 2021-06-14
- Completion
- 2021-06-14
- First posted
- 2019-06-18
- Last updated
- 2020-05-14
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03989635. Inclusion in this directory is not an endorsement.