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A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. (EXHALE-2)

Primary Purpose

Eosinophilic Asthma, Asthma; Eosinophilic, Asthma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexpramipexole Dihydrochloride
Placebo
Sponsored by
Areteia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Asthma focused on measuring Exacerbations, Severe Asthma, Dexpramipexole, EXHALE, Areteia, EXHALE-2, Uncontrolled Asthma, Asthma Attack

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent form and assent form, as appropriate Male or female ≥12 years of age at Screening Visit 1 Asthma-related criteria Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1. Treatment of asthma, participants must satisfy all the below (items a to c): Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1. Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1. Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2. Variable airflow obstruction documented with at least one of the following criteria: Bronchodilator reversibility at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV₁, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17). Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening period, at an unscheduled visit at least 7 days prior to baseline. Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1. Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1. Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine <8 mg/mL) documented in the past past 24 months prior to Screening Visit 1. ACQ-6 ≥1.5 at Screening Visit 2. Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period prior to Screening Visit 1. General medical history Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening Visit 2 and Baseline Visit. WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit: A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective Intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive. Or Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply: Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. Exclusion Criteria: Asthma-related criteria A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening Visit 1 up to and including the Baseline Visit. Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening Visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status. 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. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1. For participants aged 12 to 17 years old, AEC of <0.15x10⁹/L at Screening Visit 1. Prohibited medications/procedures Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long-acting anti-IL-5) in the past 12 months. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab. Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year. General medical history Weight <40 kg at Screening Visit 2. Current smoking within the 12 months prior to Screening Visit 1 or a smoking history of >10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use. Known or suspected alcohol or drug abuse Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to the Baseline Visit despite antihypertensive therapy. 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. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C. 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. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements. Known or suspected noncompliance with medication. Unwillingness or inability to follow the procedures outlined in the protocol. Clinical safety labs Absolute neutrophil count (ANC) <2.000x10⁹/L at Screening Visit 1 or Screening Visit 2. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² at Screening Visit 2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula for age ≥18 years at screening; using the Bedside Schwartz eGFR formula for age <18). Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at Screening Visit 2 confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart. Cardiac safety History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction <25%. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation. History of long QT syndrome. Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 ms for females at Screening Visit 2 or QTcF ≥480 ms for participants with bundle branch block. Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including heart rate <45 beats per minute (bpm) or >100 bpm. Pregnancy/Lactation Pregnant women or women breastfeeding Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).

Sites / Locations

  • Research Site 20001-062Recruiting
  • Research Site 20001-043Recruiting
  • Research Site 20001-003Recruiting
  • Research Site 20001-048Recruiting
  • Research Site 20001-005Recruiting
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  • Research Site 20001-029Recruiting
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  • Research Site 20001-002Recruiting
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  • Research Site 20001-001Recruiting
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  • Research Site 20001-026Recruiting
  • Research Site 20001-065Recruiting
  • Research Site 20001-024Recruiting
  • Research Site 20001-069Recruiting
  • Research Site 20001-004Recruiting
  • Research Site 20001-075Recruiting
  • Research Site 20001-018Recruiting
  • Research Site 20001-090Recruiting
  • Research Site 20001-036Recruiting
  • Research Site 20001-044Recruiting
  • Research Site 20001-021Recruiting
  • Research Site 20001-019Recruiting
  • Research Site 20001-055Recruiting
  • Research Site 20001-006Recruiting
  • Research Site 20001-074Recruiting
  • Research Site 20001-046Recruiting
  • Research Site 20001-050Recruiting
  • Research Site 20001-039Recruiting
  • Research Site 20001-034Recruiting
  • Research Site 20001-017Recruiting
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  • Research Site 20001-038Recruiting
  • Research Site 20001-079Recruiting
  • Research Site 20001-032Recruiting
  • Research Site 20001-025Recruiting
  • Research Site 20001-073Recruiting
  • Research Site 20001-068Recruiting
  • Research Site 20001-023Recruiting
  • Research Site 20001-028Recruiting
  • Research Site 20001-064Recruiting
  • Research Site 20001-085Recruiting
  • Research Site 20001-072Recruiting
  • Research Site 20055-012Recruiting
  • Research Site 20055-004Recruiting
  • Research Site 20055-014Recruiting
  • Research Site 20055-009Recruiting
  • Research Site 20055-002Recruiting
  • Research Site 20055-001Recruiting
  • Research Site 20055-011Recruiting
  • Research Site 20055-005Recruiting
  • Research Site 20055-003Recruiting
  • Research Site 20359-008Recruiting
  • Research Site 20359-010Recruiting
  • Research Site 20359-005Recruiting
  • Research Site 20359-009Recruiting
  • Research Site 20359-006Recruiting
  • Research Site 20359-003Recruiting
  • Research Site 20995-001Recruiting
  • Research Site 20995-002Recruiting
  • Research Site 20995-003Recruiting
  • Research Site 20995-004Recruiting
  • Research Site 20082-003Recruiting
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  • Research Site 20082-009Recruiting
  • Research Site 20082-006Recruiting
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  • Research Site 20048-001Recruiting
  • Research Site 20048-021Recruiting
  • Research Site 20048-010Recruiting
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  • Research Site 20048-014Recruiting
  • Research Site 200040-004Recruiting
  • Research Site 200040-006Recruiting
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  • Research Site 20040-004Recruiting
  • Research Site 20381-002Recruiting
  • Research Site 20381-003Recruiting
  • Research Site 20381-007Recruiting
  • Research Site 20381-001Recruiting
  • Research Site 20381-003Recruiting
  • Research Site 20044-001Recruiting
  • Research Site 20044-033Recruiting
  • Research Site 20044-046Recruiting
  • Research Site 20044-013Recruiting
  • Research Site 20044-008Recruiting
  • Research Site 20044-010Recruiting
  • Research Site 20044-018Recruiting
  • Research Site 20044-021Recruiting
  • Research Site 20044-017Recruiting
  • Research Site 20044-022Recruiting
  • Research Site 20044-019Recruiting
  • Research Site 20044-020Recruiting
  • Research Site 20044-031Recruiting
  • Research Site 20044-032Recruiting
  • Research Site 20044-009Recruiting
  • Research Site 20044-005Recruiting
  • Research Site 20044-030Recruiting
  • Research Site 20044-012Recruiting
  • Research Site 20044-004Recruiting
  • Research Site 20044-024Recruiting
  • Research Site 20044-026Recruiting
  • Research Site 20044-029Recruiting
  • Research Site 20044-034Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

150 mg BID

75 mg BID

Placebo

Arm Description

Dexpramipexole 150 mg oral tablet taken twice a day

Dexpramipexole 75 mg oral tablet taken twice a day

Placebo oral tablet taken twice a day

Outcomes

Primary Outcome Measures

Annualized rate of severe asthma exacerbations over 52 weeks.
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids; or death due to asthma.

Secondary Outcome Measures

Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
The absolute change from baseline in pre-bronchodilator forced expiratory volume, averaged across visits at Weeks 36, 44, and 52.
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)
Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52.
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 52.
Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
Annualized Rate of severe exacerbations from Week 4 to Week 52
Average change in absolute eosinophil count (AEC)
Average change from baseline in forced vital capacity (FVC)
Change from baseline in forced vital capacity (FVC)
Change from baseline in Post-bronchodilator FEV₁
Change from baseline in peak expiratory flow (PEF)
Time to first severe asthma exacerbation
Change from baseline in total asthma symptom score
Change from baseline in the EuroQol five-dimensional questionnaire (EQ-5D-5L)

Full Information

First Posted
February 20, 2023
Last Updated
October 10, 2023
Sponsor
Areteia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05763121
Brief Title
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
Acronym
EXHALE-2
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Areteia Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.
Detailed Description
This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Asthma, Asthma; Eosinophilic, Asthma
Keywords
Exacerbations, Severe Asthma, Dexpramipexole, EXHALE, Areteia, EXHALE-2, Uncontrolled Asthma, Asthma Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1395 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
150 mg BID
Arm Type
Experimental
Arm Description
Dexpramipexole 150 mg oral tablet taken twice a day
Arm Title
75 mg BID
Arm Type
Experimental
Arm Description
Dexpramipexole 75 mg oral tablet taken twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet taken twice a day
Intervention Type
Drug
Intervention Name(s)
Dexpramipexole Dihydrochloride
Intervention Description
oral administration of dexpramipexole tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration of placebo tablet
Primary Outcome Measure Information:
Title
Annualized rate of severe asthma exacerbations over 52 weeks.
Description
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids; or death due to asthma.
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Secondary Outcome Measure Information:
Title
Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
Description
The absolute change from baseline in pre-bronchodilator forced expiratory volume, averaged across visits at Weeks 36, 44, and 52.
Time Frame
Day 1 (baseline, pre-dose), Weeks 36, 44, 52
Title
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)
Description
Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52.
Time Frame
Day 1 (baseline, pre-dose), Weeks 36, 44, 52
Title
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 52.
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Title
Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Title
Annualized Rate of severe exacerbations from Week 4 to Week 52
Time Frame
Week 4 through Week 52
Title
Average change in absolute eosinophil count (AEC)
Time Frame
Day 1 (baseline, pre-dose) Weeks 36, 44, 52
Title
Average change from baseline in forced vital capacity (FVC)
Time Frame
Day 1 (baseline, pre-dose), Weeks 36, 44, 52
Title
Change from baseline in forced vital capacity (FVC)
Time Frame
Day 1 (baseline, pre-dose), Weeks 4, 12, 20,28 36, 44, 52
Title
Change from baseline in Post-bronchodilator FEV₁
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Title
Change from baseline in peak expiratory flow (PEF)
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Title
Time to first severe asthma exacerbation
Time Frame
Up to Week 52
Title
Change from baseline in total asthma symptom score
Time Frame
Day 1 (baseline, pre-dose) through Week 52
Title
Change from baseline in the EuroQol five-dimensional questionnaire (EQ-5D-5L)
Time Frame
Day 1 (baseline, pre-dose) through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form and assent form, as appropriate Male or female ≥12 years of age at Screening Visit 1 Asthma-related criteria Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1. Treatment of asthma, participants must satisfy all the below (items a to c): Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1. Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1. Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2. Variable airflow obstruction documented with at least one of the following criteria: Bronchodilator reversibility at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV₁, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17). Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening period, at an unscheduled visit at least 7 days prior to baseline. Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1. Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1. Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine <8 mg/mL) documented in the past past 24 months prior to Screening Visit 1. ACQ-6 ≥1.5 at Screening Visit 2. Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period prior to Screening Visit 1. General medical history Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening Visit 2 and Baseline Visit. WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit: A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective Intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive. Or Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply: Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. Exclusion Criteria: Asthma-related criteria A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening Visit 1 up to and including the Baseline Visit. Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening Visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status. 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. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1. For participants aged 12 to 17 years old, AEC of <0.15x10⁹/L at Screening Visit 1. Prohibited medications/procedures Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long-acting anti-IL-5) in the past 12 months. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab. Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year. General medical history Weight <40 kg at Screening Visit 2. Current smoking within the 12 months prior to Screening Visit 1 or a smoking history of >10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use. Known or suspected alcohol or drug abuse Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to the Baseline Visit despite antihypertensive therapy. 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. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C. 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. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements. Known or suspected noncompliance with medication. Unwillingness or inability to follow the procedures outlined in the protocol. Clinical safety labs Absolute neutrophil count (ANC) <2.000x10⁹/L at Screening Visit 1 or Screening Visit 2. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² at Screening Visit 2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula for age ≥18 years at screening; using the Bedside Schwartz eGFR formula for age <18). Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at Screening Visit 2 confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart. Cardiac safety History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction <25%. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation. History of long QT syndrome. Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 ms for females at Screening Visit 2 or QTcF ≥480 ms for participants with bundle branch block. Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including heart rate <45 beats per minute (bpm) or >100 bpm. Pregnancy/Lactation Pregnant women or women breastfeeding Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EXHALE Recruiting
Phone
888-584-9281
Email
clinicaltrials@areteiatx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salman Siddiqui, MD
Organizational Affiliation
Imperial College Healthcare NHS Trust (via Imperial Consultants)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site 20001-062
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-043
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-003
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-048
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-005
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-051
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-029
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-014
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-054
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-067
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-020
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-015
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-002
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34746
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-086
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-066
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-001
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-059
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-026
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-065
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-024
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-069
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-004
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-075
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-018
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-090
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-036
City
Elwood
State/Province
Indiana
ZIP/Postal Code
46036
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-044
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-021
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-019
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-055
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-006
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-074
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-046
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-050
City
E. Amherst
State/Province
New York
ZIP/Postal Code
14051
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-039
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-034
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-017
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-063
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-038
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-079
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-032
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-025
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-073
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-068
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-023
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-028
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-064
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-085
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20001-072
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 20055-012
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-074
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-004
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-014
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-009
City
Santos
State/Province
SP
ZIP/Postal Code
11075-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-002
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18040-425
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-001
City
São Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-590
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-011
City
Campo Largo
ZIP/Postal Code
83606
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-005
City
Santo André
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20055-003
City
São Paulo
ZIP/Postal Code
05403
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site 20359-008
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20359-010
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20359-005
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20359-009
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20359-006
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20359-003
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site 20995-001
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Research Site 20995-002
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Research Site 20995-003
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Research Site 20995-004
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Research Site 20082-003
City
Anyang
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-007
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-009
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-006
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-013
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-008
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-004
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-014
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20082-010
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site 20048-001
City
Będzin
ZIP/Postal Code
42-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site 20048-021
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site 20048-010
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site 20048-016
City
Poznań
ZIP/Postal Code
61-578
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site 20048-014
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site 200040-004
City
Braşov
State/Province
Brasov
ZIP/Postal Code
500366
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site 200040-006
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400371
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site 20040-008
City
Bragadiru
ZIP/Postal Code
077025
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site 20040-002
City
Braşov
ZIP/Postal Code
500051
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site 20040-004
City
Braşov
ZIP/Postal Code
500366
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site 20381-002
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site 20381-003
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site 20381-007
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site 20381-001
City
Kragujevac
ZIP/Postal Code
3400
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site 20381-003
City
Valjevo
ZIP/Postal Code
14000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Research Site 20044-001
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
BL9 0NJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-033
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-046
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M27 0EW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-013
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
SK8 4NQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-008
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-010
City
Altrincham
ZIP/Postal Code
WA14 1PF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-018
City
Bellshill
ZIP/Postal Code
ML4 3NJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-021
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-017
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-022
City
Enfield Town
ZIP/Postal Code
EN3 4GS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-019
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-020
City
Manchester
ZIP/Postal Code
M15 6SE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-031
City
Manchester
ZIP/Postal Code
M20 6BA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-032
City
Manchester
ZIP/Postal Code
M23 2SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-009
City
Manchester
ZIP/Postal Code
M24 4DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-005
City
Manchester
ZIP/Postal Code
M27 8HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-030
City
Manchester
ZIP/Postal Code
M41 8AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-012
City
Manchester
ZIP/Postal Code
M42 7WJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-004
City
Manchester
ZIP/Postal Code
OL6 6HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-024
City
Preston
ZIP/Postal Code
PR2 9RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-026
City
Rochdale
ZIP/Postal Code
OL11 4AU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-029
City
Stockport
ZIP/Postal Code
SK3 9NX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site 20044-034
City
Stockport
ZIP/Postal Code
SK8 5LL
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

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