Clinical trial NCT05813288: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Asthma
Asthma; Eosinophilic
Asthma
Keywords: Exacerbations
Severe Asthma
Dexpramipexole
EXHALE
Areteia
EXHALE-3
Uncontrolled Asthma
Asthma Attack
Lead sponsor: Areteia Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 930
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma.


Eligibility 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.

   Asthma-related criteria
3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
4. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
5. Treatment of asthma, participants must satisfy all the below (items a to c):

   1. 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 GINA 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
   2. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Visit 1. The ICS may be contained within an ICS/long-acting β2 agonist (LABA) 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.
   3. 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.
6. Pre-BD FEV₁ ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
7. Variable airflow obstruction documented with at least one of the following criteria:

   1. 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.
   2. Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1 or during Screening.
   3. Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1 or during Screening.
   4. Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1.
   5. Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine \<8 mg/mL or other clinically relevant bronchoprovocation testing) documented in the past 24 months prior to Screening Visit 1 or during Screening.
8. ACQ-6 ≥1.5 at Screening Visit 2.
9. 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
10. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits.
11. WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit:

    1. 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
    2. 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:
    3. Women \<50 years old will 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.
    4. Women ≥50 years old will 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

1. 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.

   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.
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, or lung diseases (eg, 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.

   Prohibited medications/procedures
4. 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.
5. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
6. Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
7. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
8. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year.

   General medical history
9. Weight \<40 kg at Screening Visit 1.
10. Current smoking within 12 months prior to Screening Visit 1 or a smoking history of \>10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use.
11. Known or suspected alcohol or drug abuse
12. Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to Baseline Visit despite anti-hypertensive therapy.
13. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 5 years prior to Baseline Visit.
14. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C.
15. A helminth parasitic infection diagnosed within 24 weeks prior Screening Visit 1 that has not been treated with or has failed to respond to standard of care (SoC) therapy.
16. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements.
17. Known or suspected noncompliance with medication.
18. Unwillingness or inability to follow the procedures outlined in the protocol.

    Clinical safety labs
19. Absolute neutrophil count \<2.000x10⁹/L at screening at Screening Visit 1 or Screening Visit 2.
20. 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 \[Levey et al, 2009\] for age ≥18 years at screening; using the Bedside Schwartz \[Schwartz and Work, 2009\] eGFR formula for age \<18).
21. 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
22. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%.
23. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit.
24. History of cardiac arrhythmia within 3 months prior to Baseline Visit that is not controlled by medication or via ablation.
25. History of long QT syndrome.
26. 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.
27. 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
28. Pregnant women or women breastfeeding.
29. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
30. Allergy or hypersensitivity to dexpramipexole or any of its components.

Primary outcomes:
measure: Annualized rate of severe asthma exacerbations over 52 weeks.
timeFrame: Day 1 (baseline, pre-dose) through Week 52
Secondary outcomes:
measure: Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) from Baseline
timeFrame: Day 1 (baseline, pre-dose), Weeks 36, 44, 52
measure: Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6 (ACQ-6) (Key Secondary Endpoint)
timeFrame: From randomization to Study Week 52
measure: Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Total Score (Key Secondary Endpoint)
timeFrame: From randomization to Study Week 52
measure: Annualized rate of severe exacerbations requiring an emergency over 52 weeks department visit or hospitalization
timeFrame: Day 1 (baseline, pre-dose), Week 52
measure: Annualized rate of severe exacerbations (AAER) from Week 4 to Week 52.
timeFrame: Week 4 through Week 52
measure: Change in absolute eosinophil count (AEC)
timeFrame: Day 1 (baseline, pre-dose), Weeks 35, 44, and 52
measure: Average change from baseline in forced vital capacity (FVC)
timeFrame: Day 1(baseline, pre-dose), Weeks 36, 44, and 52
measure: FVC, change from baseline at Weeks 4, 12, 20, 28, 36, 44, and 52.
timeFrame: Day 1(baseline, pre-dose), Weeks 4, 12, 20, 28, 36, 44, and 52.
measure: Post-bronchodilator FEV₁, change from baseline to Week 52
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Time to first severe asthma exacerbation
timeFrame: Up to Week 52
measure: Mean Change From Baseline at Week 52 in Asthma Symptom Diary (ASD)
timeFrame: From randomization to Study Week 52
measure: Mean Change From Baseline at Week 52 in EQ-5D-5L
timeFrame: At Study Week 52
Other outcomes:
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city: Cape Town
country: South Africa
facility: Research Site 30027-012
city: Cape Town
country: South Africa
facility: Research Site 30027-021
city: Durban
country: South Africa
facility: Research Site 30027-007
city: Durban
country: South Africa
facility: Research Site 30027-001
city: Durban
country: South Africa
facility: Research Site 30027-014
city: Durban
country: South Africa
facility: Research Site 30027-023
city: Durban
country: South Africa
facility: Research Site 30027-010
city: Johannesburg
country: South Africa
facility: Research Site 30027-030
city: Johannesburg
country: South Africa
facility: Research Site 30027-026
city: Krugersdorp
country: South Africa
facility: Research Site 30027-031
city: KwaZulu
country: South Africa
facility: Research Site 30027-008
city: Plettenberg Bay
country: South Africa
facility: Research Site 30027-032
city: Polokwane
country: South Africa
facility: Research Site 30027-029
city: Pretoria
country: South Africa
facility: Research Site 30027-004
city: Pretoria
country: South Africa
facility: Research Site 30027-019
city: Thabazimbi
country: South Africa
facility: Research Site 30027-015
city: Vereeniging
country: South Africa
facility: Research Site 30027-018
city: Welkom
country: South Africa
facility: Research Site 30027-017
city: A Coruna
country: Spain
facility: Research Site 30034-046
city: A Coruna
country: Spain
facility: Research Site 30034-052
city: Barcelona
country: Spain
facility: Research Site 30034-011
city: Barcelona
country: Spain
facility: Research Site 30034-049
city: Barcelona
country: Spain
facility: Research Site 30034-013
city: Lugo
country: Spain
facility: Research Site 30034-021
city: Madrid
country: Spain
facility: Research Site 30034-053
city: Madrid
country: Spain
facility: Research Site 30034-037
city: Madrid
country: Spain
facility: Research Site 30034-045
city: Santander
country: Spain
facility: Research Site 30034-050
city: Valencia
country: Spain
facility: Research Site 30034-043
city: Vigo
country: Spain
facility: Research Site 30034-041
city: Douliu
country: Taiwan
facility: Research Site 30886-013
city: New Taipei City
country: Taiwan
facility: Research Site 30886-004
city: New Taipei City
country: Taiwan
facility: Research Site 30886-006
city: Taichung
country: Taiwan
facility: Research Site 30886-005
city: Taichung
country: Taiwan
facility: Research Site 30886-007
city: Tainan
country: Taiwan
facility: Research Site 30886-011
city: Taipei
country: Taiwan
facility: Research Site 30886-010
city: Taipei
country: Taiwan
facility: Research Site 30886-008
city: Taipei
country: Taiwan
facility: Research Site 30886-003
city: Taipei
country: Taiwan
facility: Research Site 30886-009
city: Ankara
country: Turkey
facility: Research Site 30090-018
city: Ankara
country: Turkey
facility: Research Site 30090-021
city: Ankara
country: Turkey
facility: Research Site 30090-008
city: Ankara
country: Turkey
facility: Research Site 30090-009
city: Bornova
country: Turkey
facility: Research Site 30090-019
city: Istanbul
country: Turkey
facility: Research Site 30090-020
city: Mersin
country: Turkey
facility: Research Site 30090-013
city: Chernivtsi
country: Ukraine
facility: Research Site 30380-002
city: Kyiv
country: Ukraine
facility: Research Site 30380-011
city: Glasgow
country: United Kingdom
facility: Research Site 30044-027
city: High Wycombe
country: United Kingdom
facility: Research Site 30044-059
city: Leicester
country: United Kingdom
facility: Research Site 30044-039
city: Sheffield
country: United Kingdom
facility: Research Site 30044-025
Study officials:
affiliation: National Jewish Health
name: Michael E. Wechsler, MD
role: PRINCIPAL_INVESTIGATOR
References: