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

1395 patients around the world

Available in United States, Brazil

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.

Areteia Therapeutics

1395Patients around the world

This study is for people with

Asthma

Eosinophilic asthma

Requirements for the patient

To 99 Years

All Gender

Medical requirements

: 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):
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:
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 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.
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
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.
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).

StudyEXHALE-2

SponsorAreteia Therapeutics

Study typeInterventional

Conditions

Eosinophilic asthma

Requirements

To 99 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05763121