Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma (AS201)
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|ClinicalTrials.gov Identifier: NCT04046939|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Asthma Asthma||Drug: low-dose dexpramipexole Drug: mid-dose dexpramipexole Drug: high-dose dexpramipexole Drug: placebo oral tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Four-arm parallel assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: low-dose dexpramipexole
Oral dexpramipexole tablet low-dose (37.5 mg BID)
Drug: low-dose dexpramipexole
dexpramipexole low-dose BID
Other Name: KNS-760704
Experimental: mid-dose dexpramipexole
Oral dexpramipexole tablet mid-dose (75 mg BID)
Drug: mid-dose dexpramipexole
dexpramipexole mid-dose BID
Other Name: KNS-760704
Experimental: high-dose dexpramipexole
Oral dexpramipexole tablet high-dose (150 mg BID)
Drug: high-dose dexpramipexole
dexpramipexole high-dose BID
Other Name: KNS-760704
Placebo Comparator: placebo
Oral placebo tablet (BID)
Drug: placebo oral tablet
- Change in blood absolute eosinophil count from Baseline to Week 12 [ Time Frame: 12 weeks ]Blood absolute eosinophil count will be collected at each study visit.
- Change in pre-bronchodilator FEV1 from Baseline to Week 12 [ Time Frame: 12 weeks ]FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.
- Change in Asthma Control Questionnaire (ACQ-7) score from Baseline to Week 12 [ Time Frame: 12 weeks ]ACQ-7 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 7-point self-administered scale has items measuring asthma symptoms, rescue inhaler use, and FEV1.
- Change in post-bronchodilator FEV1 from Baseline to Week 12 [ Time Frame: 12 weeks ]Post-bronchodilator FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation, after treatment with inhaled albuterol.
- Change in quality of life, as measured by the Asthma Quality of Life Questionnaire (AQLQ) from Baseline to Week 12 [ Time Frame: 12 weeks ]The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma. The 32 questions in the AQLQ are divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
- Change in pharyngeal and nasal eosinophil peroxidase concentration from Baseline to Week 12 [ Time Frame: 12 weeks ]Pharyngeal and nasal eosinophil peroxidase is a biomarker for respiratory tissue eosinophils.
- Change in blood absolute blood basophil count from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Change in blood eosinophil progenitor population from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Change in fractional exhaled nitric oxide (FeNO) from Baseline to Week 12 [ Time Frame: 12 weeks ]FeNO is non-invasive biomarker of airway inflammation in asthma participants.
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): NCT04046939
|Contact: James L Matheremail@example.com|
|Contact: Calman Prussin, MDfirstname.lastname@example.org|
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