A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

• Status: Completed
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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