A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
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|ClinicalTrials.gov Identifier: NCT03810183|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: QAW039 Drug: Placebo||Phase 2|
The study consists of a screening period during which the subject's phenotype and eligibility for the study will be assessed. All subjects will undergo induction of their sputum to examine the baseline sputum cell counts. Subjects will be required to demonstrate both blood and sputum eosinophilia to be eligible for participation in the study. Eligible subjects will be randomized 3:2 to active (QAW039 orally daily) vs. placebo arms.
Subjects will continue their standard of care COPD and other medications during the entire course of the study.
Subjects will receive multiple doses of fevipiprant for six weeks, with safety, efficacy/pharmacodynamic and pharmacokinetic assessments performed.
Sputum induction will be repeated at the end of the treatment period and at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
This is a subject and investigator-blinded study. Subjects, investigators and all site staff will remain blinded to study treatment throughout the study.
Unblinding a single subject at site for safety reasons (if necessary for subject management) will occur via an emergency system in place at the site.
The identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance, and odor.
The sponsor may be unblinded to the study treatment at any time, especially in case of a safety concern.
|Official Title:||A Multi-center, Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia|
|Estimated Study Start Date :||May 24, 2019|
|Estimated Primary Completion Date :||July 21, 2020|
|Estimated Study Completion Date :||August 18, 2020|
QAW039 450 mg
QAW039 450 mg
Placebo Comparator: Placebo
- Change in sputum eosinophil % of total cell count [ Time Frame: 6 weeks ]Change from baseline in sputum eosinophil % of total cell count in COPD patients with eosinophilia after multiple oral doses of fevipiprant when compared to placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810183
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticals|