PER-023-23尚未招募3 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
- 3 期
- 状态
- 尚未招募
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 and assent form, as appropriate.
- •2.Male or female =12 years of age at randomization.
- •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 withmedium or high dose inhaled corticosteroids (ICS; =500 µg/dayfluticasone propionate dry powder formulation daily or clinicallycomparable, per GINA 2021) on a regular basis for at least12 months prior to screening. Equivalent medium and high doseICS doses are detailed in Appendix C
- •b.Documented treatment with a stable dose of either medium or highdose ICS for at least 3 months prior to Visit 1. The ICS may becontained within an ICS/long-acting ß2 agonist (LABA)combination product. As noted in Section 5.2.2, daily oralcorticosteroids are an allowed concomitant medication;participants on daily oral corticosteroids must be on a stable dosefor 3 months before Screening Visit 1.
- •c.Use of one of more additional daily maintenance asthma controllermedications according to standard practice of care is required;eg, LABA, leukotriene antagonist, theophylline, long-actingmuscarinic antagonists, cromolyn/nedocromil. Use of a stable doseof any additional asthma controller medications must bedocumented 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 followingcriteria:
- •a.Bronchodilator reversibility during screening, as evidenced by=12% and =200 mL improvement in FEV1, 15 to 30 minutesfollowing inhalation of 400 µg (four puffs) of albuterol/salbutamol(=12% and =160 mL for ages 12 to 17). Participants who do notmeet the bronchodilator reversibility inclusion criterion but have=10% and =160 mL reversibility, may repeat the reversibilityspirometry assessment once during the Screening period, at anunscheduled visit at least 7 days prior to baseline.
- •b.Bronchodilator reversibility, using the criteria above, documentedin the past 12 months.
- •c.Peak flow variation of =20% over a 2-week period, documented inthe past 12 months.
- •d.Airflow variability in clinic FEV1 =20% between two consecutiveclinic visits, documented in the past 12 months.
- •e.Airway hyperresponsiveness (provocative concentration causing a20% fall in FEV1 of methacholine <8 mg/mL) documented in thepast 12 months.
- •7.ACQ-6 =1.5 at Screening.
- •8.Documented history of at least two asthma exacerbations requiringtreatment with systemic corticosteroids (intramuscular, intravenous, ororal) within the past 12-month period.
- •9.Negative urine pregnancy test for women of childbearing potential(WOCBP; after menarche) at Screening and Baseline.
- •10.WOCBP must use either of the methods of birth control detailed in the protocol, from Screening through the End of Study Visit:
排除标准
- •1.A participant who experiences a severe asthma exacerbation (defined as adeterioration of asthma that results in emergency treatment, hospitalizationdue to asthma, or treatment with systemic corticosteroids) at any time from4 weeks prior to the Screening Visit up to and including the Baseline Visit.Participants who experience an asthma exacerbation during theScreening/Run-in Period may remain in screening and proceed with studyvisits 14 days after they have completed their course of oral steroids orreturned to their pre-Screening Visit maintenance dose of oral steroids andthe investigator considers participant has returned to baseline status.
- •2.Current diagnosis of diseases which may confound interpretation of thisstudy’s findings such as allergic bronchopulmonary aspergillosis,eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinaldiseases, hypereosinophilic syndrome, chronic obstructive pulmonarydisease, idiopathic pulmonary fibrosis.
- •3.Respiratory infection: Upper or lower respiratory tract, sinus, or middle earinfection within the 4 weeks before Screening.
- •4.For participants aged 12 to 17 years old, AEC of <0.15x109/L atScreening.
- •5.Treatment with a biologic investigational drug in the last 5 months.Treatment with non-biologic investigational drugs in the previous 30 daysor 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 within120 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 ofneutropenia in the past 30 days (see Appendix A).
- •9.Bronchial thermoplasty procedure in the past 12 months or planned duringthe 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 ordiastolic 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 the5 years prior to randomization.
- •15.History of human immunodeficiency virus (HIV) infection or chronicinfection with hepatitis B or C.
- •16.A helminth parasitic infection diagnosed within 24 weeks prior to the dateinformed consent, and assent when applicable, that has not been treatedwith or has failed to respond to standard of care (SoC) therapy.
- •17.Medical or other condition likely to interfere with participant’s ability toundergo study procedures, adhere to visit schedule, or comply with studyrequirements.
- •18.Known or suspected noncompliance with medication.
- •19.Unwillingness or inability to follow the procedures outlined in theprotocol.
- •20.Absolute neutrophil count <2.000x109/L at screening.
- •21.Renal dysfunction, defined as an estimated glomerular filtration rate(eGFR) <60 mL/min/1.73m2 at Screening (using the Chronic KidneyDisease Epidemiology Collaboration [CKD-EPI] formula [Levey et al,2009] for age =18 years at screening; using the Bedside Schwartz[Schwartz and Work, 2009] e
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