A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
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
2 other identifiers
interventional
517
15 countries
138
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2016
Longer than P75 for phase_2 asthma
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2016
CompletedFirst Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedResults Posted
Study results publicly available
December 28, 2022
CompletedDecember 28, 2022
November 1, 2022
2.5 years
September 27, 2016
March 31, 2022
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in Rate of Asthma Exacerbations
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.
Baseline to Week 54
Secondary Outcomes (10)
Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Baseline to Week 54
Time to First Asthma Exacerbation
52 Weeks
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Week 54
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
Baseline to Week 54
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
Baseline through Week 54
- +5 more secondary outcomes
Study Arms (4)
MSTT1041A 210 mg
EXPERIMENTALParticipants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
MSTT1041A 490 mg
EXPERIMENTALParticipants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
MSTT1041A 70 mg
EXPERIMENTALParticipants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
Alabama Allergy & Asthma
Birmingham, Alabama, 35209, United States
Del Sol Research Management
Tucson, Arizona, 85710, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, 93301, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, 90808, United States
CA Allergy & Asthma Med Grp; Medical Group, Inc.
Los Angeles, California, 90025, United States
Jonathan Corren MD, Inc.
Los Angeles, California, 90025, United States
Office of Robert N Wolfe MD
Los Angeles, California, 90048, United States
Advances in Medicine
Rancho Mirage, California, 92270, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Bensch Research Associates
Stockton, California, 95207, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, 80907, United States
Western States Clinical Research, Inc
Wheat Ridge, Colorado, 80033, United States
Yale University School Of Medicine
New Haven, Connecticut, 06519, United States
Emerald Coast Research Associates
Panama City, Florida, 32405, United States
Florida Premier Research Institute
Winter Park, Florida, 32789, United States
Atlanta Allergy & Asth Clin PC
Stockbridge, Georgia, 30281, United States
Asthma & Allergy of Idaho
Twin Falls, Idaho, 83301, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, 21236, United States
Chesapeake Clinical Research Inc - CRN
Baltimore, Maryland, 21236, United States
Genesis Clinical Research & Consulting, LLC
Fall River, Massachusetts, 02720, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, 02747, United States
Midwest Clinical Research LLC
St Louis, Missouri, 63141, United States
The Allergy and Asthma Center
Bellevue, Nebraska, 68123, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
American Health Research Inc.
Charlotte, North Carolina, 28277, United States
Allergy & Respiratory Center
Canton, Ohio, 44718, United States
Integrity People Services Research Company
Oklahoma City, Oklahoma, 73103, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, 74136, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island, 02865, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Clinical Research Solutions PC
Knoxville, Tennessee, 37920, United States
Meharry Medical College; Clinical Trials Office
Nashville, Tennessee, 37208, United States
TTS Research
Boerne, Texas, 78006, United States
Elliot J. Ginchansky, MD, PA
Dallas, Texas, 75230, United States
Pioneer Research Solutions
Houston, Texas, 077099, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069, United States
Allergy & Asthma Research Center
San Antonio, Texas, 78229, United States
Allergy Associates of Utah
Murray, Utah, 84107, United States
Commonwealth Clinical Research Specialists
Richmond, Virginia, 23226, United States
Washington Univ School of Med
Seattle, Washington, 98195, United States
Fundacion Cidea
Buenos Aires, C1121ABE, Argentina
INAER
Buenos Aires, C1425BEN, Argentina
Fundacion Scherbovsky
Mendoza, M5500AYB, Argentina
INSARES
Mendoza, Mendoza City, M5500CCG, Argentina
Centro Respiratorio Quilmes
Quilmes, B1878FNR, Argentina
Instituto Especialidades de la Salud Rosario
Rosario, S2000DBS, Argentina
Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
Rosario, S2000JKE, Argentina
Centro Modelo de Cardiologia
San Miguel de Tucumán, 4000, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR, Argentina
CEMER Centro Medico de Enfermedades Respiratorias
Vicente López, B1602DQD, Argentina
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, 5101, Belgium
Military Medical Academy HBAT
Pleven, 5800, Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, 7002, Bulgaria
Medical Centre Mladost Med 1 EOOD
Sofia, 1000, Bulgaria
First MHAT; Clinic of Neurology
Sofia, 1142, Bulgaria
Fifth MHAT - Sofia EAD
Sofia, 1233, Bulgaria
National Multiprofile Hospital Tsar Boris III
Sofia, 1233, Bulgaria
Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
Sofia, 1431, Bulgaria
Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
Sofia, 1431, Bulgaria
Medical Center N.I. Pirogov EOOD
Sofia, 1606, Bulgaria
Alitera - Med - Medical Center EOOD
Sofia, 1618, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000, Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, 5000, Bulgaria
Aggarwal and Associates
Brampton, Ontario, L6T 0G1, Canada
Cheema Research
Mississauga, Ontario, L5A 3V4, Canada
Inspiration Research
Toronto, Ontario, M5T 3A9, Canada
Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X 5A6, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
MediTrial s.r.o.
Jindřichův Hradec, 377 01, Czechia
EUC Klinika Ostrava a.s.
Ostrava-Poruba, 708 00, Czechia
Ordinace pro tuberkulozu a respiracni nemoci
Strakonice, 38601, Czechia
KASMED s.r.o.
Tábor, 390 01, Czechia
Alergologie Teplice, s.r.o.
Teplice, 415 01, Czechia
Pneumologisches Forschungsinstitut Hohegeest
Geesthacht, 21502, Germany
POIS Leipzig Gbr
Leipzig, 04357, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, 55131, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Greenlane Clinical Centre
Auckland, 1051, New Zealand
Medical Research Institute of New Zealand
Wellington, 6021, New Zealand
Clinica Internacional
Lima, Lima 1, Peru
Abk Reuma Srl- Medicentro
Lima, Lima 21, Peru
Clinica Ricardo Palma; THORAX
Lima, Lima 27, Peru
Instituto Peruano de Investigacion en Ciencias Medicas
Lima, Lima 32, Peru
Clinica San Borja
Lima, Lima 41, Peru
Hospital Santa Rosa Piura
Piura, 20001, Peru
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, 15-003, Poland
Centrum Medyczne ALL-MED
Krakow, 30-033, Poland
Malopolskie Centrum Alergologii
Krakow, 31-624, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Specjalistyczna Poradnia Pulmonologiczna
Ostrów Wielkopolski, 63-400, Poland
Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
Radom, 26-600, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, 33-100, Poland
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
Wroclaw, 53-301, Poland
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
Wroclaw, 54-239, Poland
Theramed SRL
Brasov, 16, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
Cluj-Napoca, 400371, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, 200515, Romania
Fundatia CardioPrevent
Timișoara, 300134, Romania
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, 300310, Romania
Clinical Emergency Hospital n.a.N.V. Soloviev
Yaroslavl, Moscow Oblast, 150003, Russia
LLC - ABC Medicina
Moscow, Sankt-Peterburg, 117574, Russia
City Hospital #5
Barnaul, 656045, Russia
Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
Kemerovo, 650099, Russia
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
Moscow, 115446, Russia
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, 630008, Russia
City Clinical Hospital #2
Novosibirsk, 630051, Russia
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, 390026, Russia
Clinic Reavita LLC
Saint Petersburg, 194295, Russia
SHI Ctr Occupational Pathology
Saint Petersburg, 195271, Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, 197089, Russia
City Hospital #40 of Resort Administrative District
Saint Petersburg, 197706, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Tiervalei Trial Centre
Cape Town, 7530, South Africa
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, 7700, South Africa
St Augustines Hospital; Infectoilogy
Durban, 4001, South Africa
Vawda Z.Fa Practice
Durban, 4091, South Africa
Aliwal Shoal Medical Center
eMkhomazi, 4170, South Africa
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate, 58005, Ukraine
Municipal institution; City hospital #1; Department of Therapy
Zaporizhzhia, Kherson Governorate, 69104, Ukraine
Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
Kyiv, KIEV Governorate, 02091, Ukraine
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, 49000, Ukraine
Ukrainian State Institute of Medical and Social Problems of Disability
Dnipropetrovsk, 49027, Ukraine
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, 76018, Ukraine
SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv, 61039, Ukraine
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, 03680, Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, 04107, Ukraine
Kyiv City Clinical Hospital #8
Kyiv, 04201, Ukraine
City Hospital #1
Mykolaiv, 54003, Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
Small Business Private Enterprise Medical Centre Pulse
Vinnytsia, 21001, Ukraine
Related Publications (2)
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.
PMID: 36253275DERIVEDKelsen 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.
PMID: 33872652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Comunications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 28, 2016
Study Start
September 20, 2016
Primary Completion
April 5, 2019
Study Completion
July 26, 2019
Last Updated
December 28, 2022
Results First Posted
December 28, 2022
Record last verified: 2022-11