EUCTR2022-003004-33-PL招募中1 期
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 - EXHALE-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,395
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent form.
- •2.Male or female =18 years of age at randomization.
- •Asthma-related criteria
- •3.Documented physician diagnosis of asthma for =12 months.
- •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 (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. Equivalent medium and high dose ICS doses are detailed in Appendix C
- •b.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 ß2 agonist (LABA) combination product. As noted in Section 5.2.2, 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.
- •c.Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required; eg, LABA, leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to screening.
- •5.Pre-BD FEV1 =40% and <80% of predicted at Screening.
- •6.Variable airflow obstruction documented with at least one of the following criteria:
- •a.Bronchodilator reversibility during screening, as evidenced by =12% and =200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 µg (four puffs) of albuterol/salbutamol. 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.
- •b.Bronchodilator reversibility, using the criteria above, documented in the past 12 months.
- •c.Peak flow variation of =20% over a 2-week period, documented in the past 12 months.
- •d.Airflow variability in clinic FEV1 =20% between two consecutive clinic visits, documented in the past 12 months.
- •e.Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV1 of methacholine <8 mg/mL) documented in the past 12 months.
- •7.ACQ-6 =1.5 at Screening.
- •8.Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period.
- •General medical history
- •9.Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at Screening and Baseline.
- •10.WOCBP must use either of the following methods of birth control, from Screening through the End of Study Visit:
- •a.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.
- •b.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
排除标准
- •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 the Screening Visit 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.
- •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.
- •4.Not applicable in Poland where all participants are at least 18 years of age: For participants aged 12 to 17 years old, AEC of <0.15x10ˆ9/L at Screening.
- •Prohibited medications/procedures
- •5.Treatment with a biologic investigational drug in the last 5 months. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives, whichever is longer. Treatment with GSK3511294 (long-acting anti-IL-5) in the past 12 months.
- •6.Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
- •7.Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
- •8.Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days (see Appendix A).
- •9.Bronchial thermoplasty procedure in the past 12 months or planned during the coming year.
- •10.Weight <40 kg.
- •11.Current smoking within the past year or a smoking history of >10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use.
- •12.Known or suspected alcohol or drug abuse
- •13.Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization 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 randomization.
- •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 the date informed consent, and assent when applicable, 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 <2.000x10ˆ9/L at screening.
- •21.Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 at Screening (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [Levey et al, 2009] for age =18 years at screening; us
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