A randomized, subject- and investigator-blinded, placebo-controlled, multi-center, multiple dose study to assess the efficacy and safety of CJM112 in patients with inadequately controlled moderate to severe asthma

ovartis Pharma AG0 个研究点目标入组 110 人开始时间: 2017年11月2日最近更新: 2019年11月25日

研究概览

暂无简介。

•1. Patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening.
•2. Patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at least one additional asthma controller medication (such as inhaled long-acting bronchodilator, leukotriene antagonist, theophylline, stable low dose glucocorticoid, etc).
•3. Acceptable and reproducible spirometry with FEV1 = 40 and = 90% of predicted at screening and baseline (re-testing is allowed once).
•4. ACQ score = 1.5 at screening and baseline (re-testing is allowed once).
•5. Total serum IgE < 150 IU/mL
•6. Peripheral blood eosinophils <300/µL.
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Previous use of biologics or other concomitant medications within the time periods specified in the SOM/protocol.
•2. History of ongoing, chronic, or recurrent moderate or severe infectious disease.
•3. Patients who have smoked or inhaled nicotine or tobacco products within the 6 month period prior to Visit 1 or who have a smoking history of greater than 10 pack years.
•4. Patients who have had an asthma attack/exacerbation requiring systemic corticosteroids for at least 3 continuous days within 4 weeks prior to screening.
•5. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 or during the screening period.
•6. Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.

发起方