Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918019
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: MSTT1041A Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MSTT1041A 210 mg
Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807

Experimental: MSTT1041A 490 mg
Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807

Experimental: MSTT1041A 70 mg
Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807

Placebo Comparator: Placebo
Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Drug: Placebo
Placebo matched with MSTT1041A.




Primary Outcome Measures :
  1. Rate of Asthma Exacerbations [ Time Frame: Baseline up to Week 54 ]

Secondary Outcome Measures :
  1. Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 54 [ Time Frame: Baseline up to Week 54 ]
  2. Time to First Asthma Exacerbation [ Time Frame: 52 Weeks ]
  3. Percentage of Participants with Improvement Increase in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score Greater than or Equal to (>/=) 0.5 Points [ Time Frame: Baseline up to Week 54 ]
  4. Percentage of Participants With Improvement Decrease in Asthma Control Questionnaire-5 (ACQ-5) >/= 0.5 Points [ Time Frame: Baseline up to Week 54 ]
  5. Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54 [ Time Frame: Baseline up to Week 54 ]
  6. Percentage of Weeks Without Patient-reported Asthma-related Night Time Awakenings [ Time Frame: Baseline up to Week 54 ]
  7. Change From Baseline in Patient-reported Daytime Asthma Symptoms Severity at Week 54, as Measured by Asthma Daily Symptom Diary [ Time Frame: Baseline up to Week 54 ]
  8. Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 70 ]
  9. Percentage of Participants With Anti-drug Antibodies (ADAs) [ Time Frame: Baseline up to Week 70 ]
  10. Percentage of Participants With Treatment Emergent ADAs [ Time Frame: Baseline up to Week 70 ]
  11. Serum Concentration of MSTT1041A [ Time Frame: Baseline up to Week 70 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918019


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Alabama Allergy & Asthma
Birmingham, Alabama, United States, 35209
United States, Arizona
Del Sol Research Management
Tucson, Arizona, United States, 85710
United States, California
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States, 93301
Allianz Medical and Research Center
Fountain Valley, California, United States, 92708
Allergy & Asthma Care Center of Southern California
Long Beach, California, United States, 90808
CA Allergy & Asthma Med Grp; Medical Group, Inc.
Los Angeles, California, United States, 90025
Jonathan Corren MD, Inc.
Los Angeles, California, United States, 90025
Office of Robert N Wolfe MD
Los Angeles, California, United States, 90048
Advances in Medicine
Rancho Mirage, California, United States, 92270
Allergy & Asthma Consultants
Redwood City, California, United States, 94063
Bensch Research Associates
Stockton, California, United States, 95207
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Colorado
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States, 80907
Colorado Allergy & Asthma Centers, Pc
Denver, Colorado, United States, 80230
Western States Clinical Research, Inc
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Research Institute of South Florida Inc
Miami, Florida, United States, 33173
Emerald Coast Research Associates
Panama City, Florida, United States, 32405
Florida Premier Research Institute
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Allergy & Asth Clin PC
Stockbridge, Georgia, United States, 30281
United States, Idaho
Asthma & Allergy of Idaho
Twin Falls, Idaho, United States, 83301
United States, Maryland
Asthma, Allergy & Sinus Center
Baltimore, Maryland, United States, 21236
Chesapeake Clinical Research Inc - CRN
Baltimore, Maryland, United States, 21236
United States, Massachusetts
Genesis Clinical Research & Consulting, LLC
Fall River, Massachusetts, United States, 02720
Infinity Medical Research Inc
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
Midwest Clinical Research LLC
Saint Louis, Missouri, United States, 63141
United States, Nebraska
The Allergy and Asthma Center
Bellevue, Nebraska, United States, 68123
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
American Health Research Inc.
Charlotte, North Carolina, United States, 28207
Hickory Research Center
Hickory, North Carolina, United States, 28601
United States, Ohio
Allergy & Respiratory Center
Canton, Ohio, United States, 44718
Allied Clinical Research LLC
Springfield, Ohio, United States, 45502
United States, Oklahoma
Integrity People Services Research Company
Oklahoma City, Oklahoma, United States, 73103
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, United States, 97504
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island, United States, 02865
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Clinical Research Solutions PC
Knoxville, Tennessee, United States, 37920
Meharry Medical College; Clinical Trials Office
Nashville, Tennessee, United States, 37208
United States, Texas
TTS Research
Boerne, Texas, United States, 78006
Elliot J. Ginchansky, MD, PA
Dallas, Texas, United States, 75230
Western Sky Medical Research
El Paso, Texas, United States, 79903
Pioneer Research Solutions
Houston, Texas, United States, 077099
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States, 75069
Allergy & Asthma Research Center
San Antonio, Texas, United States, 78229
United States, Utah
Allergy Associates of Utah
Murray, Utah, United States, 84107
United States, Virginia
Commonwealth Clinical Research Specialists
Richmond, Virginia, United States, 23226
United States, Washington
Washington Univ School of Med
Seattle, Washington, United States, 98195
Argentina
Fundacion Cidea
Buenos Aires, Argentina, C1125 ABE
INAER
Ciudad Autónoma de Buenos Aires, Argentina, C1425BEN
INSARES
Mendoza, Mendoza City, Argentina, M5500CCG
Fundación Scherbovsky
Mendoza, Argentina, 5500
Centro Respiratorio Quilmes
Quilmes, Argentina, 1878
Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
Rosario, Argentina, 2000
Instituto Especialidades de la Salud Rosario
Rosario, Argentina, 2000
Centro Modelo de Cardiologia
San Miguel de Tucuman, Argentina, 4000
Investigaciones en Patologias Respiratorias
San Miguel de Tucuman, Argentina, 4000
CEMER Centro Medico de Enfermedades Respiratorias
Vicente López, Argentina, B1602DQD
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Private Practice Dr Jean Benoit Martinot
Erpent, Belgium, 5101
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Bulgaria
Military Medical Academy HBAT
Pleven, Bulgaria, 5800
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Ruse, Bulgaria, 7002
Medical Centre Mladost Med 1 EOOD
Sofia, Bulgaria, 1000
First MHAT; Clinic of Neurology
Sofia, Bulgaria, 1142
Fifth MHAT - Sofia EAD
Sofia, Bulgaria, 1233
National Multiprofile Hospital Tsar Boris III
Sofia, Bulgaria, 1233
Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
Sofia, Bulgaria, 1431
Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
Sofia, Bulgaria, 1431
Medical Center N.I. Pirogov EOOD
Sofia, Bulgaria, 1606
Alitera - Med - Medical Center EOOD
Sofia, Bulgaria, 1618
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, Bulgaria, 6000
Medical Center Tara OOD
Veliko Tarnovo, Bulgaria, 5000
Canada, Ontario
Aggarwal and Associates Lilmited
Brampton, Ontario, Canada, L6T 0G1
Cheema Research, Inc
Mississauga, Ontario, Canada, L5A 3V4
Inspiration Research Limited
Toronto, Ontario, Canada, M5T 3A9
Manna Research
Toronto, Ontario, Canada, M9W 4L6
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada, G8T 7A1
Czechia
MediTrial s.r.o.
Jindřichův Hradec, Czechia, 377 01
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
EUC Klinika Ostrava a.s.
Ostrava-Poruba, Czechia, 708 00
Ordinace pro tuberkulozu a respiracni nemoci
Strakonice, Czechia, 38601
KASMED s.r.o.
Tabor, Czechia, 390 01
Alergologie Teplice, s.r.o.
Teplice, Czechia, 415 01
Germany
Pneumologisches Forschungsinstitut Hohegeest
Geesthacht, Germany, 21502
Hamburger Institut fur Therapieforschung GmbH
Hamburg, Germany, 20354
Praxis Dr. Axel Kroker
Koblenz, Germany, 56068
POIS Leipzig Gbr
Leipzig, Germany, 4358
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, Germany, 55131
Universitätsklinikum Münster
Münster, Germany, 48149
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Ajou University Hospital
Suwon City, Korea, Republic of, 443-721
New Zealand
Greenlane Clinical Centre
Auckland, New Zealand, 1051
Medical Research Institute of New Zealand
Wellington, New Zealand, 6021
Peru
Clinica Internacional
Lima, Peru, Lima 1
Abk Reuma Srl- Medicentro
Lima, Peru, Lima 21
Clinica Ricardo Palma; THORAX
Lima, Peru, Lima 27
Instituto Peruano de Investigacion en Ciencias Medicas
Lima, Peru, Lima 32
Clinica San Borja
Lima, Peru, Lima 41
Hospital Santa Rosa Piura
Piura, Peru, 20001
Poland
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, Poland, 15-003
Centrum Medyczne ALL-MED
Krakow, Poland, 30-033
Malopolskie Centrum Alergologii
Krakow, Poland, 31-624
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Kraków, Poland, 31-637
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-153
Specjalistyczna Poradnia Pulmonologiczna
Ostrow Wielkopolski, Poland, 63-400
Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
Radom, Poland, 26-600
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnow, Poland, 33-100
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
Wroclaw, Poland, 53-301
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
Wroclaw, Poland, 54-239
Romania
Theramed SRL
Brasov, Romania, 16
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
Cluj-Napoca, Romania, 400371
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, Romania, 200515
Fundatia CardioPrevent
Timisoara, Romania, 300134
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timisoara, Romania, 300310
Russian Federation
Clinical Emergency Hospital n.a.N.V. Soloviev
Yaroslavl, Moskovskaja Oblast, Russian Federation, 150003
LLC - ABC Medicina
Moscow, Sankt Petersburg, Russian Federation, 117574
City Hospital #5
Barnaul, Russian Federation, 656045
Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
Kemerovo, Russian Federation, 650099
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
Moscow, Russian Federation, 115446
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, Russian Federation, 630008
City Clinical Hospital #2
Novosibirsk, Russian Federation, 630051
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, Russian Federation, 390011
Clinic Reavita LLC
St. Petersburg, Russian Federation, 194295
SHI Ctr Occupational Pathology
St. Petersburg, Russian Federation, 195271
St. Petersburg State Medical University n.a. I.P. Pavlov
St. Petersburg, Russian Federation, 197089
City Hospital #40 of Resort Administrative District
St. Petersburg, Russian Federation, 197706
Siberian State Medical University
Tomsk, Russian Federation, 634050
South Africa
Tiervalei Trial Centre
Cape Town, South Africa, 7530
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, South Africa, 7700
St Augustines Hospital; Infectoilogy
Durban, South Africa, 4001
Vawda Z.Fa Practice
Durban, South Africa, 4091
Aliwal Shoal Medical Center
Umkomaas, South Africa, 4170
Ukraine
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate, Ukraine, 58005
Municipal institution; City hospital #1; Department of Therapy
Zaporizhzhia, Kherson Governorate, Ukraine, 69104
Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
Kyiv, KIEV Governorate, Ukraine, 02091
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnepropetrovsk, Ukraine, 49000
Ukrainian State Institute of Medical and Social Problems of Disability
Dnipropetrovsk, Ukraine, 49027
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, Ukraine, 76018
SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv, Ukraine, 61039
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, Ukraine, 03680
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, Ukraine, 04107
Kyiv City Clinical Hospital #8
Kyiv, Ukraine, 04201
City Hospital #1
Mykolaiv, Ukraine, 54003
Municipal Institution Odesa Regional Clinical Hospital
Odesa, Ukraine, 65025
Small Business Private Enterprise Medical Centre Pulse
Vinnytsya, Ukraine, 21001
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02918019     History of Changes
Other Study ID Numbers: GB39242
2016-001549-13 ( EudraCT Number )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases