CTIS2023-503693-20-00进行中（未招募）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-3) - AR-DEX-22-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 854
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •Signed informed consent form and assent form, as appropriate., Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at Screening and Baseline., WOCBP (after menarche) must use either of the following methods of birth control, from Screening Visit 1 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 IUS, or oral contraceptive. Or 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 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: c. 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. d. 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., Male or female =12 years of age at Screening Visit 1., Documented physician diagnosis of asthma for =12 months prior to Screening Visit 1., 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)., 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 Visit 1. 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 Screening 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 or 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 Visit 1., 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: a. 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%
排除标准
- •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 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., 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 anti-hypertensive 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., Absolute neutrophil count <2.000x109/L at Screening Visit 1 or Screening Visit 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)., 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)., 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., 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 impor
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