A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Status: | Active, not recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/11/2019 |
Start Date: | September 20, 2016 |
End Date: | September 19, 2019 |
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Uncontrolled Severe Asthma
This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm
study 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.
study 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.
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
We found this trial at
66
sites
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
Click here to add this to my saved trials
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1950 Sawtelle Boulevard
Los Angeles, California 90025
Los Angeles, California 90025
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1005 Doctor DB Todd Junior Boulevard
Nashville, Tennessee 37208
Nashville, Tennessee 37208
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
Click here to add this to my saved trials
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
470 Toll Gate Road
Warwick, Rhode Island 02865
Warwick, Rhode Island 02865
Click here to add this to my saved trials
Click here to add this to my saved trials
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
Click here to add this to my saved trials
Click here to add this to my saved trials