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

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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.


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
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
1444
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
1293
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Bronx, NY
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
569
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Houston, TX
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221 East 23rd
Panama City, Florida 32405
850-785-6550
869
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Panama City, FL
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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Spartanburg, SC
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884
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Albany, GA
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Asheville, North Carolina 28801
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2121 17th Street
Bakersfield, California 93301
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5430 Campbell Boulevard
Baltimore, Maryland 21236
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Baltimore, Maryland 21236
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3503 Samson Way
Bellevue, Nebraska 68123
254
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Birmingham, Alabama 35209
683
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Birmingham, AL
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Boerne, Texas 78006
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5827
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Buenos Aires,
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Canton, Ohio 44718
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Centennial, Colorado 80112
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Charlotte, North Carolina 28207
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Cincinnati, Ohio 45231
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Colorado Springs, Colorado 80907
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Dallas, Texas 75230
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6801 Emmett F Lowry Expressway
Dickinson, Texas 77539
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El Paso, Texas 79903
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Fall River, Massachusetts 02720
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Fountain Valley, California 92708
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Gastonia, North Carolina 28054
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Hickory, North Carolina 28602
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Houston, Texas 77098
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Knoxville, Tennessee 37920
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Los Angeles, California 90025
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1950 Sawtelle Boulevard
Los Angeles, California 90025
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8635 West 3rd Street
Los Angeles, California 90048
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4833 Medical Center Drive
McKinney, Texas 75069
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Medford, OR
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Miami, FL
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Murray, Utah 84107
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1005 Doctor DB Todd Junior Boulevard
Nashville, Tennessee 37208
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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North Dartmouth, Massachusetts 02747
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802 West Park Avenue
Ocean City, New Jersey 07712
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158
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1111 North Lee Avenue
Oklahoma City, Oklahoma 73103
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601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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1015 Chestnut Street
Philadelphia, Pennsylvania 19107
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Rancho Mirage, California 92270
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Redwood City, California 94063
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10330 Old Olive Street Road
Saint Louis, Missouri 63141
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1040 North Mason Road
Saint Louis, Missouri 63141
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10447 Texas 151
San Antonio, Texas 78251
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1959 Northeast Pacific Street
Seattle, Washington 98195
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Spokane, Washington 99204
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Springfield, Ohio 45502
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550 Eagles Landing Parkway
Stockbridge, Georgia 30281
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Wheat Ridge, Colorado 80033
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Winter Park, Florida 32789
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