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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 : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04046939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 2, 2019)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
Detailed Description One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12 weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week 12.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Four-arm parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Eosinophilic Asthma
  • Asthma
Intervention  ICMJE
  • Drug: low-dose dexpramipexole
    dexpramipexole low-dose BID
    Other Name: KNS-760704
  • Drug: mid-dose dexpramipexole
    dexpramipexole mid-dose BID
    Other Name: KNS-760704
  • Drug: high-dose dexpramipexole
    dexpramipexole high-dose BID
    Other Name: KNS-760704
  • Drug: placebo oral tablet
    placebo BID
Study Arms  ICMJE
  • Experimental: low-dose dexpramipexole
    Oral dexpramipexole tablet low-dose (37.5 mg BID)
    Intervention: Drug: low-dose dexpramipexole
  • Experimental: mid-dose dexpramipexole
    Oral dexpramipexole tablet mid-dose (75 mg BID)
    Intervention: Drug: mid-dose dexpramipexole
  • Experimental: high-dose dexpramipexole
    Oral dexpramipexole tablet high-dose (150 mg BID)
    Intervention: Drug: high-dose dexpramipexole
  • Placebo Comparator: placebo
    Oral placebo tablet (BID)
    Intervention: Drug: placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female ≥18 and <75 years of age at the time of consent
  • Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines
  • Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening
  • Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening
  • Pre-bronchodilator FEV1 ≥40% and <80% of predicted at Screening and Baseline
  • AEC ≥0.30 x10^9/L at the Screening visit
  • ACQ-7 ≥1.5 at Screening
  • Negative pregnancy test at Baseline
  • Adherence ≥85% with twice-daily placebo taken during the Run-in Period

Exclusion Criteria:

  • Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit
  • Treatment with systemic corticosteroids in the 8 weeks prior to Screening
  • Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline
  • Treatment with selected drugs known to have a substantial risk of neutropenia
  • Absolute neutrophil count <2.0x10^9/L at Screening, or any documented history of absolute neutrophil count <2.0x10^9/L.
  • Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2 at Screening
  • Clinically significant abnormal laboratory or ECG values
  • Other medically significant illness
  • Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening
  • Pregnant women or women breastfeeding
  • Currently taking pramipexole or other dopamine agonists
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James L Mather 4124881776 mather@knoppbio.com
Contact: Calman Prussin, MD 3017702553 calman@knoppbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04046939
Other Study ID Numbers  ICMJE KNS-760704-AS201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Knopp Biosciences
Study Sponsor  ICMJE Knopp Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Knopp Biosciences
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP