EUCTR2015-000865-29-BE进行中（未招募）1 期
A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients with Uncontrolled Asthma and Elevated Blood Eosinophils
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- 性别
- All
入选标准
- •Patients may be included in the study only if they meet all of the following criteria:
- •a. Written informed consent is obtained. A patient 12 through <18 years of age must provide assent, and their parent(s) or legal guardian(s) must provide consent.
- •b. The patient is male or female, 12 years of age and older, with a diagnosis of asthma. (Patients 12 to <18 years of age are excluded from participating in South Korea and Argentina, and patients 66 years of age and older are excluded from participating in South Korea.)
- •c. The patient has had at least 2 documented asthma exacerbations requiring the use of systemic (oral, intramuscular, or intravenous) corticosteroids within 12 months of signing the Informed Assent Form/Informed Consent Form.
- •d. The patient has an ACQ-6 score of at least 1.5 at screening (visit 1).
- •e. The patient has a blood eosinophil level of at least 300/µL during the screening period (ie, before visit 2).(A maximum of 30% of the patients with blood eosinophil levels of 300/µL to <400/µL will be enrolled. When this 30% threshold has been reached, only patients with blood eosinophil levels of =400/µL will then be enrolled).
- •f. The patient has an FEV1 reversibility of at least 12%and an absolute change of at least 200 mL after administration of inhaled SABA according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. Documented historical reversibility within 12 months of signing the Informed Assent Form/Informed Consent Form is acceptable.
- •g. The patient has required at least a medium total daily inhaled corticosteroid (ICS) dose based on Global Initiative for Asthma 2016 clinical comparability table (Appendix A) for at least 3 months. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
- •h. The patient has required an additional asthma controller medication (eg, long-acting beta-2-agonist[LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA], or theophylline preparations), besides inhaled corticosteroids, for at least 3 months or a documented failure in the past 12 months of an additional asthma controller medication for at least 3 successive months.
- •i. Females of childbearing potential (not surgically sterile by hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or 2 years postmenopausal) must have exclusively same-sex partners or use medically acceptable methods of birth control and must agree to continue use of this method for the duration of the study and for 5 months after the last study drug dose. Acceptable methods of birth control include intrauterine device, systemic hormonal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, bilateral fallopian tube occlusion, and partner vasectomy. Contraception is further clarified in an administrative letter in Section 1.1.1.
- •j. The patient must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- •k. The patient must maintain their usual asthma controller regimen without change throughout the screening and run-in periods. A patient who experiences an asthma exacerbation during this time that requires additional medication, beyond increased SABA use
排除标准
- •Patients will be excluded from participating in this study if they meet any of the following criteria:
- •a. The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient’s safety.
- •b. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, eosinophilic granulomatosis with polyangiitis [EGPA, also known as Churg-Strauss syndrome], or allergic bronchopulmonary aspergillosis [ABPA]).
- •c. The patient has a known hypereosinophilic syndrome.
- •d. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- •e. The patient is a pregnant or lactating woman, or intends to become pregnant during the study or within 5 months after the last dose of study
- •drug. Any woman becoming pregnant during the study will be withdrawn from the study.
- •f. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening/run-in period.
- •g. The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history =10 pack years.
- •h. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti-immunoglobulin E monoclonal antibody or other monoclonal antibody [eg, mepolizumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 10 mg of prednisone daily or equivalent). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed, if approved by the medical monitor.
- •i. The patient participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- •j. The patient was previously exposed to benralizumab within 12 months of screening.
- •k. The patient was previously exposed to reslizumab.
- •l. The patient has a history of an immunodeficiency disorder including HIV.
- •m. The patient has current or suspected drug and alcohol abuse.
- •n. The patient has an active helminthic parasitic infection or was treated for one within 6 months of screening.
- •o. The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
- •p. The patient has a history of latex allergy. (The current prefilled syringe device has a natural rubber component to the needle shield.)
研究者
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