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
5622
mi
from 43215
Buenos Aires,
Click here to add this to my saved trials
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...
643
mi
from 43215
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...
484
mi
from 43215
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...
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
221 East 23rd
Panama City, Florida 32405
850-785-6550
691
mi
from 43215
Panama City, FL
Click here to add this to my saved trials
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
349
mi
from 43215
Spartanburg, SC
Click here to add this to my saved trials
582
mi
from 43215
Albany, GA
Click here to add this to my saved trials
Asheville, North Carolina 28801
302
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
2121 17th Street
Bakersfield, California 93301
1980
mi
from 43215
Bakersfield, CA
Click here to add this to my saved trials
5430 Campbell Boulevard
Baltimore, Maryland 21236
352
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21236
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
3503 Samson Way
Bellevue, Nebraska 68123
683
mi
from 43215
Bellevue, NE
Click here to add this to my saved trials
Birmingham, Alabama 35209
491
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Boerne, Texas 78006
1128
mi
from 43215
Boerne, TX
Click here to add this to my saved trials
Canton, Ohio 44718
102
mi
from 43215
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado 80112
1157
mi
from 43215
Centennial, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45231
95
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Dallas, Texas 75230
911
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
1157
mi
from 43215
Denver, CO
Click here to add this to my saved trials
6801 Emmett F Lowry Expressway
Dickinson, Texas 77539
995
mi
from 43215
Dickinson, TX
Click here to add this to my saved trials
El Paso, Texas 79903
1422
mi
from 43215
El Paso, TX
Click here to add this to my saved trials
Fall River, Massachusetts 02720
631
mi
from 43215
Fall River, MA
Click here to add this to my saved trials
Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
Click here to add this to my saved trials
Gastonia, North Carolina 28054
340
mi
from 43215
Gastonia, NC
Click here to add this to my saved trials
Hickory, North Carolina 28602
306
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
Houston, Texas 77098
994
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37920
280
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
1971
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
1950 Sawtelle Boulevard
Los Angeles, California 90025
1983
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
8635 West 3rd Street
Los Angeles, California 90048
1978
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
4833 Medical Center Drive
McKinney, Texas 75069
888
mi
from 43215
McKinney, TX
Click here to add this to my saved trials
2060
mi
from 43215
Medford, OR
Click here to add this to my saved trials
997
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Murray, Utah 84107
1514
mi
from 43215
Murray, UT
Click here to add this to my saved trials
1005 Doctor DB Todd Junior Boulevard
Nashville, Tennessee 37208
333
mi
from 43215
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...
537
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
639
mi
from 43215
North Dartmouth, MA
Click here to add this to my saved trials
802 West Park Avenue
Ocean City, New Jersey 07712
474
mi
from 43215
Ocean City, NJ
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
1111 North Lee Avenue
Oklahoma City, Oklahoma 73103
849
mi
from 43215
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...
683
mi
from 43215
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...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
1015 Chestnut Street
Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Rancho Mirage, California 92270
1884
mi
from 43215
Rancho Mirage, CA
Click here to add this to my saved trials
Redwood City, California 94063
2103
mi
from 43215
Redwood City, CA
Click here to add this to my saved trials
342
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
10330 Old Olive Street Road
Saint Louis, Missouri 63141
404
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1040 North Mason Road
Saint Louis, Missouri 63141
407
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
10447 Texas 151
San Antonio, Texas 78251
1145
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1959 Northeast Pacific Street
Seattle, Washington 98195
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99204
1779
mi
from 43215
Spokane, WA
Click here to add this to my saved trials
101 North Fountain Avenue
Springfield, Ohio 45502
41
mi
from 43215
Springfield, OH
Click here to add this to my saved trials
550 Eagles Landing Parkway
Stockbridge, Georgia 30281
450
mi
from 43215
Stockbridge, GA
Click here to add this to my saved trials
Stockton, California 95207
2045
mi
from 43215
Stockton, CA
Click here to add this to my saved trials
Tucson, Arizona 85710
1633
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Twin Falls, Idaho 83301
1627
mi
from 43215
Twin Falls, ID
Click here to add this to my saved trials
Walnut Creek, California 94598
2083
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
614
mi
from 43215
Warwick, RI
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
1167
mi
from 43215
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...
484
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials
Winter Park, Florida 32789
791
mi
from 43215
Winter Park, FL
Click here to add this to my saved trials