A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
NCT ID: NCT02918019
Last Updated: 2022-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
517 participants
INTERVENTIONAL
2016-09-20
2019-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MSTT1041A 210 mg
Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
MSTT1041A 490 mg
Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
MSTT1041A 70 mg
Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Placebo
Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Placebo
Placebo matched with MSTT1041A.
Interventions
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MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Placebo
Placebo matched with MSTT1041A.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alabama Allergy & Asthma
Birmingham, Alabama, United States
Del Sol Research Management
Tucson, Arizona, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, United States
CA Allergy & Asthma Med Grp; Medical Group, Inc.
Los Angeles, California, United States
Jonathan Corren MD, Inc.
Los Angeles, California, United States
Office of Robert N Wolfe MD
Los Angeles, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Bensch Research Associates
Stockton, California, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States
Western States Clinical Research, Inc
Wheat Ridge, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Emerald Coast Research Associates
Panama City, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Atlanta Allergy & Asth Clin PC
Stockbridge, Georgia, United States
Asthma & Allergy of Idaho
Twin Falls, Idaho, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, United States
Chesapeake Clinical Research Inc - CRN
Baltimore, Maryland, United States
Genesis Clinical Research & Consulting, LLC
Fall River, Massachusetts, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, United States
Midwest Clinical Research LLC
St Louis, Missouri, United States
The Allergy and Asthma Center
Bellevue, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
American Health Research Inc.
Charlotte, North Carolina, United States
Allergy & Respiratory Center
Canton, Ohio, United States
Integrity People Services Research Company
Oklahoma City, Oklahoma, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Clinical Research Solutions PC
Knoxville, Tennessee, United States
Meharry Medical College; Clinical Trials Office
Nashville, Tennessee, United States
TTS Research
Boerne, Texas, United States
Elliot J. Ginchansky, MD, PA
Dallas, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States
Allergy & Asthma Research Center
San Antonio, Texas, United States
Allergy Associates of Utah
Murray, Utah, United States
Commonwealth Clinical Research Specialists
Richmond, Virginia, United States
Washington Univ School of Med
Seattle, Washington, United States
Fundacion Cidea
Buenos Aires, , Argentina
INAER
Buenos Aires, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
INSARES
Mendoza, Mendoza City, , Argentina
Centro Respiratorio Quilmes
Quilmes, , Argentina
Instituto Especialidades de la Salud Rosario
Rosario, , Argentina
Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
Rosario, , Argentina
Centro Modelo de Cardiologia
San Miguel de Tucumán, , Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, , Argentina
CEMER Centro Medico de Enfermedades Respiratorias
Vicente López, , Argentina
Cliniques Universitaires St-Luc
Brussels, , Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, , Belgium
Military Medical Academy HBAT
Pleven, , Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, , Bulgaria
Medical Centre Mladost Med 1 EOOD
Sofia, , Bulgaria
First MHAT; Clinic of Neurology
Sofia, , Bulgaria
Fifth MHAT - Sofia EAD
Sofia, , Bulgaria
National Multiprofile Hospital Tsar Boris III
Sofia, , Bulgaria
Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
Sofia, , Bulgaria
Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
Sofia, , Bulgaria
Medical Center N.I. Pirogov EOOD
Sofia, , Bulgaria
Alitera - Med - Medical Center EOOD
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, , Bulgaria
Aggarwal and Associates
Brampton, Ontario, Canada
Cheema Research
Mississauga, Ontario, Canada
Inspiration Research
Toronto, Ontario, Canada
Anil Dhar Professional Medicine Corporation
Windsor, Ontario, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, Canada
MediTrial s.r.o.
Jindřichův Hradec, , Czechia
EUC Klinika Ostrava a.s.
Ostrava-Poruba, , Czechia
Ordinace pro tuberkulozu a respiracni nemoci
Strakonice, , Czechia
KASMED s.r.o.
Tábor, , Czechia
Alergologie Teplice, s.r.o.
Teplice, , Czechia
Pneumologisches Forschungsinstitut Hohegeest
Geesthacht, , Germany
POIS Leipzig Gbr
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, , Germany
Universitatsklinikum Munster
Münster, , Germany
Greenlane Clinical Centre
Auckland, , New Zealand
Medical Research Institute of New Zealand
Wellington, , New Zealand
Clinica Internacional
Lima, , Peru
Abk Reuma Srl- Medicentro
Lima, , Peru
Clinica Ricardo Palma; THORAX
Lima, , Peru
Instituto Peruano de Investigacion en Ciencias Medicas
Lima, , Peru
Clinica San Borja
Lima, , Peru
Hospital Santa Rosa Piura
Piura, , Peru
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, , Poland
Centrum Medyczne ALL-MED
Krakow, , Poland
Malopolskie Centrum Alergologii
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Specjalistyczna Poradnia Pulmonologiczna
Ostrów Wielkopolski, , Poland
Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
Radom, , Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, , Poland
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
Wroclaw, , Poland
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
Wroclaw, , Poland
Theramed SRL
Brasov, , Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
Cluj-Napoca, , Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, , Romania
Fundatia CardioPrevent
Timișoara, , Romania
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, , Romania
Clinical Emergency Hospital n.a.N.V. Soloviev
Yaroslavl, Moscow Oblast, Russia
LLC - ABC Medicina
Moscow, Sankt-Peterburg, Russia
City Hospital #5
Barnaul, , Russia
Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
Kemerovo, , Russia
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
Moscow, , Russia
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, , Russia
City Clinical Hospital #2
Novosibirsk, , Russia
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, , Russia
Clinic Reavita LLC
Saint Petersburg, , Russia
SHI Ctr Occupational Pathology
Saint Petersburg, , Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, , Russia
City Hospital #40 of Resort Administrative District
Saint Petersburg, , Russia
Siberian State Medical University
Tomsk, , Russia
Tiervalei Trial Centre
Cape Town, , South Africa
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, , South Africa
St Augustines Hospital; Infectoilogy
Durban, , South Africa
Vawda Z.Fa Practice
Durban, , South Africa
Aliwal Shoal Medical Center
eMkhomazi, , South Africa
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate, Ukraine
Municipal institution; City hospital #1; Department of Therapy
Zaporizhzhia, Kherson Governorate, Ukraine
Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
Kyiv, KIEV Governorate, Ukraine
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, , Ukraine
Ukrainian State Institute of Medical and Social Problems of Disability
Dnipropetrovsk, , Ukraine
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, , Ukraine
SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv, , Ukraine
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, , Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Kyiv City Clinical Hospital #8
Kyiv, , Ukraine
City Hospital #1
Mykolaiv, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
Small Business Private Enterprise Medical Centre Pulse
Vinnytsia, , Ukraine
Countries
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References
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Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
Kelsen SG, Agache IO, Soong W, Israel E, Chupp GL, Cheung DS, Theess W, Yang X, Staton TL, Choy DF, Fong A, Dash A, Dolton M, Pappu R, Brightling CE. Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: A randomized clinical trial. J Allergy Clin Immunol. 2021 Sep;148(3):790-798. doi: 10.1016/j.jaci.2021.03.044. Epub 2021 Apr 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001549-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB39242
Identifier Type: -
Identifier Source: org_study_id