Inadequately controlled moderate to severe asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CJM112
Pharmaceutical Form: Solution for injection
Other descriptive name: CJM112
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether treatment with CJM112 in patients with inadequately controlled moderate to severe asthma leads to an improvement in airflow obstruction as reflected by change from baseline in FEV1 in mL.; Secondary Objective: To determine whether treatment with CJM112 in patients with inadequately controlled moderate to severe asthma: 1. leads to an improvement in FEV1% of predicted. 2. leads to an improvement in asthma control as reflected by change from baseline in ACQ score 3. is safe and well tolerated by evaluating study treatment discontinuations and adverse events ;Primary end point(s): Change from baseline FEV1 in mL.;Timepoint(s) of evaluation of this end point: Baseline, Day 92. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline FEV1 % of predicted. 2. Change from baseline in ACQ score. 3. % of patients with = 0.5 decrease in ACQ score. 4. Study treatment discontinuation and adverse events. ; Timepoint(s) of evaluation of this end point: 1. Baseline, Day 92. 2. Baseline, Day 92. 3. Baseline, Day 92. 4. End of Study. | — |
Countries
Argentina, Belgium, China, Denmark, France, Germany, Israel, Slovakia, United States
Contacts
Public ContactMedical Information
Novartis Healthcare A/S
Outcome results
None listed