Severe Eosinophilic Asthma MedDRA version: 21.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Dexpramipexole 75mg
Product Code: KNS-760704
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dexpramipexole
CAS Number: 908244-04-2
Current Sponsor code: KNS-760704
Other
Sponsors
Areteia Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form and assent form, as appropriate. 2.Male or female =12 years of age at Screening Visit 1. a. Participants in Poland must be =18 years of age at Screening Visit 1. 3. Documented physician diagnosis of asthma for =12 months prior to Screening Visit 1. 4.Treatment of asthma, participants must satisfy all the below (items a to c): a.Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids on a regular basis for at least 12 months prior to Screening Visit 1. b.Documented treatment with a stable dose for at least 3 months prior to Screening Visit 1. c.Use of one of more additional daily maintenance asthma controller. 5.Pre-BD FEV1 =40% and =65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: 1.A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the Screening Visit 1 up to and including the Baseline Visit. 2.Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, hypereosinophilic syndrome, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis. 3.Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1. 4.For participants aged 12 to 17 years old, AEC of 10 pack-years. 12.Known or suspected alcohol or drug abuse 13.Uncontrolled severe hypertension prior to he Baseline Visi despite anti-hypertensive therapy. 14.History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 5 years prior to the Baseline Visit. 15.History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C. 16.A helminth parasitic infection diagnosed within 24 weeks prior to Screening Visit 1 that has not been treated with or has failed to respond to standard of care (SoC) therapy. 17.Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements. 18.Known or suspected noncompliance with medication. 19.Unwillingness or inability to follow the procedures outlined in the protocol. 20.Absolute neutrophil count 450 ms for males and >470 ms for females at Screening Visit 2 or QTcF =480 ms for participants with bundle branch block. 28.Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval. 29.Pregnant women or women br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the efficacy of dexpramipexole in reducing severe asthma exacerbations.;Secondary Objective: • To demonstrate the efficacy of dexpramipexole on pulmonary function. • To demonstrate the efficacy of dexpramipexole on asthma control and quality of life • To evaluate the effect of dexpramipexole on blood eosinophils.;Primary end point(s): •Annualized rate of severe asthma exacerbations (AAER) over 52 weeks.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Pre-BD FEV1, absolute change from baseline, averaged across visits at Weeks 36, 44, and 52. •Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52. •Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) change from baseline to Week 52. ;Timepoint(s) of evaluation of this end point: Please refer to the clinical study Protocol | — |
Countries
Argentina, Brazil, Bulgaria, Colombia, Georgia, Korea, Republic of, Mexico, North Macedonia, Poland, Romania, Serbia, United Kingdom, United States
Contacts
Public ContactAndrew Friedman
Areteia Therapeutics, Inc.
Outcome results
None listed