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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

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Four-arm parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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
placebo BID




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. Change in blood absolute blood basophil count from Baseline to Week 12 [ Time Frame: 12 weeks ]
  3. Change in blood eosinophil progenitor population from Baseline to Week 12 [ Time Frame: 12 weeks ]
  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: James L Mather 4124881776 mather@knoppbio.com
Contact: Calman Prussin, MD 3017702553 calman@knoppbio.com

  Show 25 Study Locations
Sponsors and Collaborators
Knopp Biosciences

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Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT04046939     History of Changes
Other Study ID Numbers: KNS-760704-AS201
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Knopp Biosciences:
Eosinophilic Asthma
Asthma
dexpramipexole
Additional relevant MeSH terms:
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Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents