Clinical trial NCT02918019: A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in Rate of Asthma Exacerbations
timeFrame: Baseline to Week 54
Secondary outcomes:
measure: Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline to Week 54
measure: Time to First Asthma Exacerbation
timeFrame: 52 Weeks
measure: Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
timeFrame: Week 54
measure: Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
timeFrame: Baseline to Week 54
measure: Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
timeFrame: Baseline through Week 54
measure: Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
timeFrame: Baseline to Week 54
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline to Week 54
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs)
timeFrame: Baseline
measure: Serum Concentration of Astegolimab (MSTT1041A)
timeFrame: Weeks 26 and 54
measure: Percentage of Participants With Treatment-Emergent ADAs
timeFrame: From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy & Asthma
state: Alabama
city: Tucson
country: United States
facility: Del Sol Research Management
state: Arizona
city: Bakersfield
country: United States
facility: Kern Allergy Med Clinic, Inc.
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center of Southern California
state: California
city: Los Angeles
country: United States
facility: CA Allergy & Asthma Med Grp; Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Jonathan Corren MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Office of Robert N Wolfe MD
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research, Inc.
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy; Associates, P.C.
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Panama City
country: United States
facility: Emerald Coast Research Associates
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute
state: Florida
city: Stockbridge
country: United States
facility: Atlanta Allergy & Asth Clin PC
state: Georgia
city: Twin Falls
country: United States
facility: Asthma & Allergy of Idaho
state: Idaho
city: Baltimore
country: United States
facility: Asthma, Allergy & Sinus Center
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Clinical Research Inc - CRN
state: Maryland
city: Fall River
country: United States
facility: Genesis Clinical Research & Consulting, LLC
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research Inc
state: Massachusetts
city: Saint Louis
country: United States
facility: Midwest Clinical Research LLC
state: Missouri
city: Bellevue
country: United States
facility: The Allergy and Asthma Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc.
state: North Carolina
city: Canton
country: United States
facility: Allergy & Respiratory Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integrity People Services Research Company
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clin Res Pc
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Warwick
country: United States
facility: Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Knoxville
country: United States
facility: Clinical Research Solutions PC
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College; Clinical Trials Office
state: Tennessee
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Dallas
country: United States
facility: Elliot J. Ginchansky, MD, PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonology & Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Research Center
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Richmond
country: United States
facility: Commonwealth Clinical Research Specialists
state: Virginia
city: Seattle
country: United States
facility: Washington Univ School of Med
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: INAER
city: Mendoza, Mendoza City
country: Argentina
facility: INSARES
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: Rosario
country: Argentina
facility: Instituto Especialidades de la Salud Rosario
city: Rosario
country: Argentina
facility: Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
city: San Miguel de Tucuman
country: Argentina
facility: Centro Modelo de Cardiologia
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Vicente López
country: Argentina
facility: CEMER Centro Medico de Enfermedades Respiratorias
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Pleven
country: Bulgaria
facility: Military Medical Academy HBAT
city: Ruse
country: Bulgaria
facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
city: Sofia
country: Bulgaria
facility: Medical Centre Mladost Med 1 EOOD
city: Sofia
country: Bulgaria
facility: First MHAT; Clinic of Neurology
city: Sofia
country: Bulgaria
facility: Fifth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: National Multiprofile Hospital Tsar Boris III
city: Sofia
country: Bulgaria
facility: Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
city: Sofia
country: Bulgaria
facility: Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
city: Sofia
country: Bulgaria
facility: Medical Center N.I. Pirogov EOOD
city: Sofia
country: Bulgaria
facility: Alitera - Med - Medical Center EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Tara OOD
city: Brampton
country: Canada
facility: Aggarwal and Associates
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research
state: Ontario
city: Windsor
country: Canada
facility: Anil Dhar Professional Medicine Corporation
state: Ontario
city: Trois-Rivières
country: Canada
facility: C.I.C. Mauricie
state: Quebec
city: Jindřichův Hradec
country: Czechia
facility: MediTrial s.r.o.
city: Ostrava-Poruba
country: Czechia
facility: EUC Klinika Ostrava a.s.
city: Strakonice
country: Czechia
facility: Ordinace pro tuberkulozu a respiracni nemoci
city: Tabor
country: Czechia
facility: KASMED s.r.o.
city: Teplice
country: Czechia
facility: Alergologie Teplice, s.r.o.
city: Geesthacht
country: Germany
facility: Pneumologisches Forschungsinstitut Hohegeest
city: Leipzig
country: Germany
facility: POIS Leipzig Gbr
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Wellington
country: New Zealand
facility: Medical Research Institute of New Zealand
city: Lima
country: Peru
facility: Clinica Internacional
city: Lima
country: Peru
facility: Abk Reuma Srl- Medicentro
city: Lima
country: Peru
facility: Clinica Ricardo Palma; THORAX
city: Lima
country: Peru
facility: Instituto Peruano de Investigacion en Ciencias Medicas
city: Lima
country: Peru
facility: Clinica San Borja
city: Piura
country: Peru
facility: Hospital Santa Rosa Piura
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Robert M. Mróz
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Kraków
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Ostrow Wielkopolski
country: Poland
facility: Specjalistyczna Poradnia Pulmonologiczna
city: Radom
country: Poland
facility: Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
city: Tarnow
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
city: Wroclaw
country: Poland
facility: Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
city: Wroclaw
country: Poland
facility: NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
city: Brasov
country: Romania
facility: Theramed SRL
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
city: Craiova
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
city: Timisoara
country: Romania
facility: Fundatia CardioPrevent
city: Timisoara
country: Romania
facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a.N.V. Soloviev
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: LLC - ABC Medicina
state: Sankt Petersburg
city: Barnaul
country: Russian Federation
facility: City Hospital #5
city: Kemerovo
country: Russian Federation
facility: Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
city: Moscow
country: Russian Federation
facility: I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #2
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University Named after I.P.Pavlov
city: St. Petersburg
country: Russian Federation
facility: Clinic Reavita LLC
city: St. Petersburg
country: Russian Federation
facility: SHI Ctr Occupational Pathology
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov
city: St. Petersburg
country: Russian Federation
facility: City Hospital #40 of Resort Administrative District
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Cape Town
country: South Africa
facility: Tiervalei Trial Centre
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute; Lung Clinical Research
city: Durban
country: South Africa
facility: St Augustines Hospital; Infectoilogy
city: Durban
country: South Africa
facility: Vawda Z.Fa Practice
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Center
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital
state: Chernihiv Governorate
city: Zaporizhzhia
country: Ukraine
facility: Municipal institution; City hospital #1; Department of Therapy
state: Kherson Governorate
city: Kyiv
country: Ukraine
facility: Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
state: KIEV Governorate
city: Dnepropetrovsk
country: Ukraine
facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
city: Dnipropetrovsk
country: Ukraine
facility: Ukrainian State Institute of Medical and Social Problems of Disability
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Phthisiology and Pulmonology Center
city: Kharkiv
country: Ukraine
facility: SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
city: Kyiv
country: Ukraine
facility: SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #8
city: Mykolaiv
country: Ukraine
facility: City Hospital #1
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Vinnytsya
country: Ukraine
facility: Small Business Private Enterprise Medical Centre Pulse
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.