A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Purpose
This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.
Condition
- Asthma
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) 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% to 80% of predicted - Evidence of uncontrolled asthma - Use of contraceptive measures
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 participants 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental MSTT1041A 210 mg |
Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50. |
|
Experimental MSTT1041A 490 mg |
Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50. |
|
Experimental MSTT1041A 70 mg |
Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50. |
|
Placebo Comparator Placebo |
Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50. |
|
More Details
- Status
- Completed
- Sponsor
- Hoffmann-La Roche