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

Use our guide to learn which trials are right for you!

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
sites
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
221 East 23rd
Panama City, Florida 32405
850-785-6550
?
mi
from
Panama City, FL
Click here to add this to my saved trials
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Albany, GA
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
2121 17th Street
Bakersfield, California 93301
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
5430 Campbell Boulevard
Baltimore, Maryland 21236
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21236
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
3503 Samson Way
Bellevue, Nebraska 68123
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boerne, Texas 78006
?
mi
from
Boerne, TX
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado 80112
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45231
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
6801 Emmett F Lowry Expressway
Dickinson, Texas 77539
?
mi
from
Dickinson, TX
Click here to add this to my saved trials
El Paso, Texas 79903
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Gastonia, North Carolina 28054
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Hickory, North Carolina 28602
?
mi
from
Hickory, NC
Click here to add this to my saved trials
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1950 Sawtelle Boulevard
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
8635 West 3rd Street
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4833 Medical Center Drive
McKinney, Texas 75069
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
1005 Doctor DB Todd Junior Boulevard
Nashville, Tennessee 37208
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
802 West Park Avenue
Ocean City, New Jersey 07712
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1111 North Lee Avenue
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
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...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1015 Chestnut Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rancho Mirage, California 92270
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
Redwood City, California 94063
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
10330 Old Olive Street Road
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
1040 North Mason Road
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
10447 Texas 151
San Antonio, Texas 78251
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1959 Northeast Pacific Street
Seattle, Washington 98195
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
101 North Fountain Avenue
Springfield, Ohio 45502
?
mi
from
Springfield, OH
Click here to add this to my saved trials
550 Eagles Landing Parkway
Stockbridge, Georgia 30281
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
Stockton, California 95207
?
mi
from
Stockton, CA
Click here to add this to my saved trials
Tucson, Arizona 85710
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Twin Falls, Idaho 83301
?
mi
from
Twin Falls, ID
Click here to add this to my saved trials
Walnut Creek, California 94598
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
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...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials