A study to compare different doses of MSTT1041A with a “placebo” – in patients with severe asthma

A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

  • Respiratory Disorder
  • Asthma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • abe
  • Auckland
  • Bakersfield
  • Barnaul
  • Bellevue
  • Berea
  • Białystok
  • Birmingham
  • Boerne
  • Brampton
  • Brașov
  • Bruxelles
  • Buenos Aires
  • Canton
  • Cape Town
  • Centennial
  • Cercado de Lima
  • Charlotte
  • Chernivtsi
  • Cluj-Napoca
  • Colorado Springs
  • Craiova
  • Dallas
  • Dartmouth
  • Dnipro
  • Fall River
  • Florida
  • Geesthacht
  • gesves
  • Houston
  • Ivano-Frankivs'k
  • Jindřichův Hradec
  • Kemerovo
  • Kharkiv
  • Knoxville
  • Kraków
  • Kyiv
  • Leipzig
  • Lima
  • Long Beach
  • Los Angeles
  • Mainz
  • McKinney
  • Mendoza
  • Mississauga
  • Moscow
  • Moskva
  • Murray
  • Mykolaiv
  • Münster
  • Nashville
  • New Haven
  • New York
  • Nottingham
  • Novosibirsk
  • Odesa
  • Oklahoma City
  • Ostrava-Poruba
  • Ostrów Wielkopolski
  • Panama City
  • Philadelphia
  • Piura
  • Providence
  • Quilmes
  • Québec
  • Radom
  • Rancho Mirage
  • Redwood City
  • Richmond
  • Rosario
  • Ruse
  • Ryazan'
  • Saint Petersburg
  • San Antonio
  • San Borja
  • San Isidro
  • San Miguel de Tucumán
  • Sankt-Peterburg
  • Seattle
  • Seoul
  • Sofia
  • Spartanburg
  • St. Louis
  • Stara Zagora
  • Stockbridge
  • Stockton
  • Strakonice
  • Tarnów
  • Teplice
  • Timișoara
  • Tomsk
  • Toronto
  • Towson
  • Tucson
  • Tulsa
  • Twin Falls
  • Tábor
  • Umkomaas
  • Veliko Tarnovo
  • Vinnytsia
  • Walnut Creek
  • Wellington
  • Wheat Ridge
  • Windsor
  • Winter Park
  • Wrocław
  • Yaroslavl
  • Zaporizhzhia
  • Łódź
  • София
Trial Identifier:

NCT02918019 2016-001549-13 GB39242

  • Abk Reuma Srl- Medicentro

    LimaPeru
  • Advances in Medicine

    42362 Bob Hope Dr92270Rancho MirageUnited States
  • Aggarwal and Associates

    490 Bramalea RdL6T 0G1BramptonCanada
  • Alabama Allergy & Asthma

    504 Brookwood Blvd35209BirminghamUnited States
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

    26 PCK33-100TarnówPoland
  • Alergologie Teplice, s.r.o.

    742/9 U Nádraží415 01TepliceCzechia
  • Alitera - Med - Medical Center EOOD

    24 bul. "Gotse Delchev"1618SofiaBulgaria
  • Aliwal Shoal Medical Center

    9344UmkomaasSouth Africa
  • Allergy & Asthma Care Center of Southern California

    3816 Woodruff Ave90808Long BeachUnited States
  • Allergy & Asthma Consultants

    369 Main St94063Redwood CityUnited States
  • Allergy & Asthma Research Center

    2414 Babcock Rd78229San AntonioUnited States
  • Allergy & Respiratory Center

    4048 Dressler Rd NW44718CantonUnited States
  • Allergy and Asthma Clinical Research, Inc.

    370 N Wiget Ln94598Walnut CreekUnited States
  • Allergy Associates of Utah

    6095 S Fashion Blvd84107MurrayUnited States
  • American Health Research Inc.

    8045 Providence Rd28270CharlotteUnited States
  • Anil Dhar Professional Medicine Corporation

    1720 Howard AveN8X 5A6WindsorCanada
  • Asan Medical Center

    05505SeoulSouth Korea
  • Asthma & Allergy of Idaho

    1502 Locust St N83301Twin FallsUnited States
  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)

    470 Toll Gate Rd02886ProvidenceUnited States
  • Asthma & Allergy; Associates, P.C.

    2709 N Tejon St80907Colorado SpringsUnited States
  • Asthma, Allergy & Sinus Center

    5430 Campbell Blvd21236NottinghamUnited States
  • Atlanta Allergy & Asth Clin PC

    830 Eagles Landing Pkwy30281StockbridgeUnited States
  • Bensch Research Associates

    4632 Georgetown Pl95207StocktonUnited States
  • C.I.C. Mauricie

    QuébecCanada
  • CA Allergy & Asthma Med Grp; Medical Group, Inc.

    1950 Sawtelle Blvd90025Los AngelesUnited States
  • CEMER Centro Medico de Enfermedades Respiratorias

    1550 EsmeraldaB1602FloridaArgentina
  • Centro Modelo de Cardiologia

    546 LapridaT4000San Miguel de TucumánArgentina
  • Centro Respiratorio Quilmes

    854 Av. Hipólito YrigoyenQuilmesArgentina
  • Centrum Medycyny Oddechowej Robert M. Mróz

    9A Piasta15-044BiałystokPoland
  • Centrum Medyczne ALL-MED

    23 Henryka Sienkiewicza30-033KrakówPoland
  • Cheema Research

    470 Hensall CirL5A 3V4MississaugaCanada
  • Chesapeake Clinical Research Inc - CRN

    6569 MD-13921204TowsonUnited States
  • City Clinical Hospital #2

    630051NovosibirskRussia
  • City Hospital #1

    54000MykolaivUkraine
  • City Hospital #40 of Resort Administrative District

    197706Sankt-PeterburgRussia
  • City Hospital #5

    53 Ulitsa Malakhova656050BarnaulRussia
  • Clinic Reavita LLC

    194295Saint PetersburgRussia
  • Clinica Internacional

    1420 Av. Inca Garcilaso de la Vega15001Cercado de LimaPeru
  • Clinica Ricardo Palma; THORAX

    1066 Av. Javier Prado Este15036San IsidroPeru
  • Clinica San Borja

    337 Av. Guardia Civil15036San BorjaPeru
  • Clinical Emergency Hospital n.a.N.V. Soloviev

    150003YaroslavlRussia
  • Clinical Research Solutions PC

    37920KnoxvilleUnited States
  • Cliniques Universitaires St-Luc

    10 Av. Hippocrate1200BruxellesBelgium
  • Commonwealth Clinical Research Specialists

    7110 Forest Ave23226RichmondUnited States
  • Del Sol Research Management

    6369 E Tanque Verde Rd85715TucsonUnited States
  • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

    TimișoaraRomania
  • Elliot J. Ginchansky, MD, PA

    7777 Forest Ln75230DallasUnited States
  • Emerald Coast Research Associates

    221 E 23rd St32405Panama CityUnited States
  • Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska

    27 Ślężna53-301WrocławPoland
  • Fifth MHAT - Sofia EAD

    SofiaBulgaria
  • First MHAT; Clinic of Neurology

    SofiaBulgaria
  • Florida Premier Research Institute

    1788 W Fairbanks Ave32789Winter ParkUnited States
  • Fundacion Cidea

    2035 ParaguayC1121abeArgentina
  • Fundacion Scherbovsky

    2760 Federico MorenoM5500MendozaArgentina
  • Fundatia CardioPrevent

    TimișoaraRomania
  • Genesis Clinical Research & Consulting, LLC

    1 Father Devalles Blvd02723Fall RiverUnited States
  • Greenlane Clinical Centre

    214 Green Ln W1051AucklandNew Zealand
  • Hospital Santa Rosa Piura

    20008PiuraPeru
  • I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

    2, стр. 4 Bol'shaya Pirogovskaya Ulitsa119435MoskvaRussia
  • IMMUNOe Research Centers

    6801 S Yosemite St80112CentennialUnited States
  • INAER

    3146 ArenalesC1425Buenos AiresArgentina
  • Infinity Medical Research Inc

    370 Faunce Corner Rd02747DartmouthUnited States
  • INSARES

    335 RondeauM5500MendozaArgentina
  • Inspiration Research

    340 College StM5T 3A9TorontoCanada
  • Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas

    2668 SaltaS2000RosarioArgentina
  • Instituto Especialidades de la Salud Rosario

    RosarioArgentina
  • Instituto Peruano de Investigacion en Ciencias Medicas

    141 Av. de los Patriotas15087Cercado de LimaPeru
  • Integrity People Services Research Company

    607 N Western Ave73106Oklahoma CityUnited States
  • Investigaciones en Patologias Respiratorias

    San Miguel de TucumánArgentina
  • Jonathan Corren MD, Inc.

    10780 CA-290025Los AngelesUnited States
  • KASMED s.r.o.

    67 Ovocná390 01TáborCzechia
  • Kern Allergy Med Clinic, Inc.

    1921 18th St93301BakersfieldUnited States
  • Kyiv City Clinical Hospital #8

    8 Yuriya Kondratyuka St04201KyivUkraine
  • Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

    02000KyivUkraine
  • LLC - ABC Medicina

    117574MoscowRussia
  • Malopolskie Centrum Alergologii

    40 Osiedle Piastów31-625KrakówPoland
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara ZagoraBulgaria
  • Medical Center N.I. Pirogov EOOD

    21 bul. "General Eduard I. Totleben"1606SofiaBulgaria
  • Medical Center Tara OOD

    9 ul. "Marno Pole"5000Veliko TarnovoBulgaria
  • Medical Centre Mladost Med 1 EOOD

    1784SofiaBulgaria
  • Medical Research Institute of New Zealand

    6021WellingtonNew Zealand
  • MediTrial s.r.o.

    95 Václavská377 01Jindřichův HradecCzechia
  • Meharry Medical College; Clinical Trials Office

    1005 Dr DB Todd Jr Blvd37208NashvilleUnited States
  • Metroplex Pulmonology & Sleep Center

    4833 Medical Center Dr75069McKinneyUnited States
  • Midwest Clinical Research LLC

    711 Old Ballas Rd63141St. LouisUnited States
  • Military Medical Academy HBAT

    5800СофияBulgaria
  • Montefiore Medical Center

    1300 Morris Park Ave10461New YorkUnited States
  • Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

    KemerovoRussia
  • Municipal Institution Odesa Regional Clinical Hospital

    9 Akademika Vorobiova St65031OdesaUkraine
  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    1 Bahhovutivska St04106KyivUkraine
  • Municipal institution; City hospital #1; Department of Therapy

    80 Peremohy St69005ZaporizhzhiaUkraine
  • National Multiprofile Hospital Tsar Boris III

    110 булевард „кн. Мария Луиза“1000SofiaBulgaria
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

    31-820KrakówPoland
  • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

    630008NovosibirskRussia
  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

    51WrocławPoland
  • Office of Robert N Wolfe MD

    8635 W 3rd St90048Los AngelesUnited States
  • Ordinace pro tuberkulozu a respiracni nemoci

    214 5. května386 01StrakoniceCzechia
  • Pioneer Research Solutions

    10700 Stancliff Rd77099HoustonUnited States
  • Pneumologisches Forschungsinstitut Hohegeest

    1 Bohnenstraße21502GeesthachtGermany
  • POIS Leipzig Gbr

    12 Tauchaer Str.04357LeipzigGermany
  • Private Practice Dr Jean Benoit Martinot

    20 Fond du Hainaut5340gesvesBelgium
  • Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED

    12 Główna26-600RadomPoland
  • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

    13 Batumska St49000KyivUkraine
  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    137 Holovna St58001ChernivtsiUkraine
  • Regional Phthisiology and Pulmonology Center

    76000Ivano-Frankivs'kUkraine
  • Ryazan State Medical University Named after I.P.Pavlov

    9 Vysokovol'tnaya Ulitsa390026Ryazan'Russia
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Severance Hospital, Yonsei University Health System

    03722SeoulSouth Korea
  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    7002RuseBulgaria
  • SHI Ctr Occupational Pathology

    195271Saint PetersburgRussia
  • SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

    KharkivUkraine
  • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

    17В вул. Дегтярівська04050KyivUkraine
  • Siberian State Medical University

    2 Moskovskiy Trakt634050TomskRussia
  • Small Business Private Enterprise Medical Centre Pulse

    21000VinnytsiaUkraine
  • Spartanburg Medical Research

    485 Simuel Rd29303SpartanburgUnited States
  • Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp

    1000SofiaBulgaria
  • Specjalistyczna Poradnia Pulmonologiczna

    33 Marszałka Józefa Piłsudskiego63-410Ostrów WielkopolskiPoland
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

    126 Calea București200515CraiovaRomania
  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

    6 Strada Bogdan Petriceicu Hasdeu400332Cluj-NapocaRomania
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    22 Dr. Stefana Kopcińskiego90-001ŁódźPoland
  • St Augustines Hospital; Infectoilogy

    107 J.B. Marks Rd4001BereaSouth Africa
  • St. Petersburg State Medical University n.a. I.P. Pavlov

    6-8 Ulitsa L'va Tolstogo197022Sankt-PeterburgRussia
  • Temple University Hospital

    3401 N Broad St19140PhiladelphiaUnited States
  • The Allergy and Asthma Center

    3503 Samson Way68123BellevueUnited States
  • Theramed SRL

    2A Strada Pictor Ion Andreescu500051BrașovRomania
  • Tiervalei Trial Centre

    7530Cape TownSouth Africa
  • TTS Research

    1420 River Rd78006BoerneUnited States
  • Ukrainian State Institute of Medical and Social Problems of Disability

    49000DniproUkraine
  • Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska

    1 ul. "Sveti Georgi Sofiyski"1431SofiaBulgaria
  • Universitatsklinikum Munster

    1 Albert-Schweitzer-Campus48149MünsterGermany
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

    1 Langenbeckstraße55131MainzGermany
  • University of Cape Town Lung Institute; Lung Clinical Research

    7700Cape TownSouth Africa
  • Vawda Z.Fa Practice

    343 Randles Rd4091BereaSouth Africa
  • Vital Prospects Clin Res Pc

    7307 S Yale Ave74136TulsaUnited States
  • Washington Univ School of Med

    1959 NE Pacific St98195SeattleUnited States
  • Western States Clinical Research, Inc

    4251 Kipling St80033Wheat RidgeUnited States
  • Yale University School Of Medicine

    15 York St06510New HavenUnited States
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which 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.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT02918019, GB39242, 2016-001549-13 Study Identifier
    All Gender
    ≥18 Years & ≤ 75 Years Age
    No Healthy Volunteers

    This clinical trial was done to study a new medicine called, “MSTT1041A”, for the treatment of patients with severe asthma. This study was done to find the dose of MSTT1041A that was effective for reducing the number of asthma exacerbations. Other questions that researchers had included finding the dose of MSTT1041A that was effective for improving other symptoms for asthma patients; time it took for MSTT1041A to be distributed in the body; whether MSTT1041A was safe for asthma patients; and whether MSTT1041A caused the immune system to make antibodies against this medicine. There were 502 patients with asthma who took part in this study at 182 study centers in 15 countries.

    Study Summary

    This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which 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.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT02918019, GB39242, 2016-001549-13 Trial Identifier
    MSTT1041A, Placebo Treatments
    Asthma Condition
    Official Title

    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

    Eligibility Criteria

    All Gender
    ≥18 Years & ≤ 75 Years Age
    No Healthy Volunteers
    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

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