EUCTR2015-000865-29-CZ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
- 468
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% 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.
- 另有 4 项未显示
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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