Uncontrolled Severe Asthma MedDRA version: 19.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10015888 Term: Extrinsic asthma System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT C
Conditions
Interventions
Product Name: MSTT1041A
Product Code: Ro 718-7807/F01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
Current Spon
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-75 years - Body mass index (BMI) of 18-35 kg/square meter (kg/m2) and weight >= 40 kg at screening - Documented physician-diagnosed asthma - On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication - Forced expiratory volume in 1 second (FEV1) of 40%-80% of predicted - Evidence of uncontrolled asthma - Use of contraceptive measures 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 401 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Diagnosis of mimics of asthma - Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator - Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A - Recent history of smoking - History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results - Asthma exacerbation within 4 weeks prior to screening - Intubation for respiratory failure due to asthma within 12 months prior to screening - Comorbid conditions that may interfere with evaluation of investigational medicinal product - Known sensitivity to any of the active substances or their excipients to be administered during dosing - Positive pregnancy test The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of MSTT1041A compared with placebo; Secondary Objective: • To evaluate the safety and efficacy of MSTT1041A compared with placebo • To evaluate the pharmacokinetics (PK) of MSTT1041A • To evaluate the immune response to MSTT1041A ; Primary end point(s): Efficacy: 1. Incidence of asthma exacerbations ;Timepoint(s) of evaluation of this end point: 1. Week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-5) Weeks 14, 26, and 54 6-7) Up to Week 70 8) Weeks 2, 14, 26, 38, 54, and 70 9) Weeks 2, 6, 10, 14, 26, 38, 50, 54, and 70 10) Weeks 2, 14, 26, 38, 54, and 70 ; Secondary end point(s): Efficacy: 1. Change in pre-bronchodilator FEV1 2. Change in patient-reported use of short-acting rescue therapy 3. Change in patient-reported asthma-related night time awakenings 4. Change in patient-reported asthma symptoms 5. Improvement in Standardized Asthma Quality-of-Life Questionnaire AQLQ(S) score Safety: 6. Incidence and severity of adverse events 7. Change in physical examination findings, vital signs, ECGs, and clinical laboratory results 8. Incidence of anti-therapeutic antibodies (ATAs) PK 9. Serum concentration of MSTT1041A Immunogenicity 10. Incidence of treatment-emergent ATAs | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Czech Republic, Germany, Korea, Republic of, New Zealand, Peru, Poland, Romania, Russian Federation, South Africa, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed