Uncontrolled Severe Asthma MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10015888 Term: Extrinsic asthma System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 MedD
Conditions
Interventions
Product Name: MSTT1041A
Product Code: Ro 718-7807/F01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
Current Sponsor code: RO7187807
Other descriptive name: MSTT1041A, anti- ST2
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-75 years - Body mass index (BMI) of 18-38 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 |
|---|---|
| Secondary end point(s): Efficacy: 1. Change in pre-bronchodilator FEV1 2. Time to first asthma exacerbation during the 52-week double blind treatment period 3. Achievement of improvement from baseline visit in ACQ-5 score 4. Change in patient-reported use of short-acting rescue therapy 5. Proportion of weeks without patient-reported asthma-related night time awakenings 6. Change in patient-reported daytime asthma symptoms 7. Achievement of improvement in AQLQ(S) score from baseline to Week 54 Safety: 8. Incidence and severity of adverse events 9. Change in physical examination findings, vital signs, ECGs, and clinical laboratory results 10. Incidence of anti-drug antibodies (ADAs) PK 11. Serum concentration of MSTT1041A Immunogenicity 12. Incidence of treatment-emergent ADAs ;Timepoint(s) of evaluation of this end point: 1. Week 54 2. Up to Week 54 3-4. Week 54 5. Up to Week 54 6-7. Week 54 8-9. Up to Week 70 10. Up to Week 70 11. Up to Week 70 12. Up to Week 70 | — |
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