EUCTR2009-010359-28-CZ进行中（未招募）不适用
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF LEBRIKIZUMAB (MILR1444A)IN ADULT PATIENTS WITH ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROIDS. - MILLY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
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 must meet the following criteria to be eligible for study entry:
- •103 Age=18 to = 65 years at Visit 1.
- •105 Chest radiography within 12 months of visit 1 with evidence of clinically significant abnormality.
- •107 Uncontrolled asthma defined by all of the following criteria:
- •- Diagnosis of asthma >12 months.
- •- Bronchodilator response at Visit 1 or 2
- •- Pre-bronchodilator FEV1 = 40% and = 80% predicted at Visit 3
- •- Required daily use of ICS = 200 µg and = 1000 µg total daily dose of fluticasone propionate or equivalent for a minimum of 6 months prior to Visit 1
- •- Demonstrated on-going asthma symptoms assessed at the end of the run-in period by ACQ score = 1.5 (for symptoms over the 7 days prior to visit 3) despite ICS compliance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •a. Medical Conditions
- •201 Asthma exacerbation, significant airflow obstruction, or respiratory infection between visits 1 and 3.
- •202 Known malignancy or current evaluation for a potential malignancy. If treatment for a malignancy was completed at least 12 months prior to Visit 1 and no further treatment is anticipated by the patient’s oncologist during this study, then the patient may enroll.
- •203 Basal or squamous cell carcinoma without documention of adequate treatment.
- •204 Known immunodeficiency, including but not limited to HIV infection.
- •205 Pre-existing lung disease other than asthma, including active infections.
- •206 Clinically significant medical disease which is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study.
- •207 Patients with elevated IgE levels for reasons other than allergy (including but not limited to parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich, Syndrome).
- •b. Exposures
- •210 Current smoker or former smoker with a lifetime smoking history of > 10 pack years.
- •211 History of substance abuse that may impair or risk the patient’s full participation in the study in the judgment of the investigator.
- •212 Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30days or 5 halv-lives if the investigational agent, whichever is longer.
- •c.Medications
- •213 Prior allergic reaction during the use (or possible use if blinded study) of a monoclonal antibody.
- •214 See excluded concomitant and previously prescribed therapies in Table 1 of the protocol.
- •d.Reproductive Potential
- •215 Patients (males and females) of reproductive potential who are not willing to use a highly effective method of contraception for the duration of the study or are pregnant or lactating at the time of randomization.
- •216 Women who are pregnant as documented by a positive serum pregnancy test (at Visit 1) or a urine pregnancy test (at Visit 3, prior to random allocation)
研究者
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