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 sites110 target enrollmentNovember 2, 2017

Overview

No summary available.

Registry

who.int

Start Date

November 2, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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.