Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Areteia Therapeutics (Voir sur ClinicalTrials)
mars 2023
février 2027
02 septembre 2025
The objective of this clinical study is to investigate the safety, tolerability, and
efficacy of dexpramipexole in participants with inadequately controlled severe
eosinophilic asthma.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | AMEL BOUDJEMAA | 28/08/2025 15:15:04 | Contacter | ||
Critères
Tous
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.