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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MSTT1041A
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alabama Allergy & Asthma
  • Del Sol Research Management
  • Kern Allergy Med Clinic, Inc.
  • Allergy & Asthma Care Center of Southern California
  • CA Allergy & Asthma Med Grp; Medical Group, Inc.
  • Jonathan Corren MD, Inc.
  • Office of Robert N Wolfe MD
  • Advances in Medicine
  • Allergy & Asthma Consultants
  • Bensch Research Associates
  • Allergy and Asthma Clinical Research, Inc.
  • IMMUNOe Research Centers
  • Asthma & Allergy; Associates, P.C.
  • Western States Clinical Research, Inc
  • Yale University School Of Medicine
  • Emerald Coast Research Associates
  • Florida Premier Research Institute
  • Atlanta Allergy & Asth Clin PC
  • Asthma & Allergy of Idaho
  • Asthma, Allergy & Sinus Center
  • Chesapeake Clinical Research Inc - CRN
  • Genesis Clinical Research & Consulting, LLC
  • Infinity Medical Research Inc
  • Midwest Clinical Research LLC
  • The Allergy and Asthma Center
  • Montefiore Medical Center
  • American Health Research Inc.
  • Allergy & Respiratory Center
  • Integrity People Services Research Company
  • Vital Prospects Clin Res Pc
  • Temple University Hospital
  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
  • Spartanburg Medical Research
  • Clinical Research Solutions PC
  • Meharry Medical College; Clinical Trials Office
  • TTS Research
  • Elliot J. Ginchansky, MD, PA
  • Pioneer Research Solutions
  • Metroplex Pulmonology & Sleep Center
  • Allergy & Asthma Research Center
  • Allergy Associates of Utah
  • Commonwealth Clinical Research Specialists
  • Washington Univ School of Med
  • Fundacion Cidea
  • INAER
  • INSARES
  • Fundacion Scherbovsky
  • Centro Respiratorio Quilmes
  • Instituto Especialidades de la Salud Rosario
  • Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
  • Centro Modelo de Cardiologia
  • Investigaciones en Patologias Respiratorias
  • CEMER Centro Medico de Enfermedades Respiratorias
  • Cliniques Universitaires St-Luc
  • Private Practice Dr Jean Benoit Martinot
  • Military Medical Academy HBAT
  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
  • Medical Centre Mladost Med 1 EOOD
  • First MHAT; Clinic of Neurology
  • Fifth MHAT - Sofia EAD
  • National Multiprofile Hospital Tsar Boris III
  • Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
  • Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
  • Medical Center N.I. Pirogov EOOD
  • Alitera - Med - Medical Center EOOD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • Medical Center Tara OOD
  • Aggarwal and Associates
  • Cheema Research
  • Inspiration Research
  • Anil Dhar Professional Medicine Corporation
  • C.I.C. Mauricie
  • MediTrial s.r.o.
  • EUC Klinika Ostrava a.s.
  • Ordinace pro tuberkulozu a respiracni nemoci
  • KASMED s.r.o.
  • Alergologie Teplice, s.r.o.
  • Pneumologisches Forschungsinstitut Hohegeest
  • POIS Leipzig Gbr
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • Universitatsklinikum Munster
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Greenlane Clinical Centre
  • Medical Research Institute of New Zealand
  • Clinica Internacional
  • Abk Reuma Srl- Medicentro
  • Clinica Ricardo Palma; THORAX
  • Instituto Peruano de Investigacion en Ciencias Medicas
  • Clinica San Borja
  • Hospital Santa Rosa Piura
  • Centrum Medycyny Oddechowej Robert M. Mróz
  • Centrum Medyczne ALL-MED
  • Malopolskie Centrum Alergologii
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Specjalistyczna Poradnia Pulmonologiczna
  • Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
  • Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
  • Theramed SRL
  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
  • Fundatia CardioPrevent
  • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
  • Clinical Emergency Hospital n.a.N.V. Soloviev
  • LLC - ABC Medicina
  • City Hospital #5
  • Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
  • I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
  • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
  • City Clinical Hospital #2
  • Ryazan State Medical University Named after I.P.Pavlov
  • Clinic Reavita LLC
  • SHI Ctr Occupational Pathology
  • St. Petersburg State Medical University n.a. I.P. Pavlov
  • City Hospital #40 of Resort Administrative District
  • Siberian State Medical University
  • Tiervalei Trial Centre
  • University of Cape Town Lung Institute; Lung Clinical Research
  • St Augustines Hospital; Infectoilogy
  • Vawda Z.Fa Practice
  • Aliwal Shoal Medical Center
  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
  • Municipal institution; City hospital #1; Department of Therapy
  • Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
  • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
  • Ukrainian State Institute of Medical and Social Problems of Disability
  • Regional Phthisiology and Pulmonology Center
  • SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
  • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Kyiv City Clinical Hospital #8
  • City Hospital #1
  • Municipal Institution Odesa Regional Clinical Hospital
  • Small Business Private Enterprise Medical Centre Pulse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MSTT1041A 210 mg

MSTT1041A 490 mg

MSTT1041A 70 mg

Placebo

Arm Description

Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.

Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.

Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
FEV1 measures how much air a person can exhale during the first second of a forced breath. Adjusted means are reported.
Time to First Asthma Exacerbation
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.
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54. Adjusted rates are reported.
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
Adjusted mean values are all equal to zero.
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.
Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable). Adjusted means are reported.
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Percentage of Participants With Anti-Drug Antibodies (ADAs)
The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.
Serum Concentration of Astegolimab (MSTT1041A)
Percentage of Participants With Treatment-Emergent ADAs
The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.

Full Information

First Posted
September 27, 2016
Last Updated
November 21, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02918019
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
517 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSTT1041A 210 mg
Arm Type
Experimental
Arm Description
Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
Arm Title
MSTT1041A 490 mg
Arm Type
Experimental
Arm Description
Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
Arm Title
MSTT1041A 70 mg
Arm Type
Experimental
Arm Description
Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Intervention Type
Drug
Intervention Name(s)
MSTT1041A
Other Intervention Name(s)
RO7187807
Intervention Description
MSTT1041A will be administered as subcutaneous injections.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched with MSTT1041A.
Primary Outcome Measure Information:
Title
Reduction in Rate of Asthma Exacerbations
Description
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.
Time Frame
Baseline to Week 54
Secondary Outcome Measure Information:
Title
Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Description
FEV1 measures how much air a person can exhale during the first second of a forced breath. Adjusted means are reported.
Time Frame
Baseline to Week 54
Title
Time to First Asthma Exacerbation
Description
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.
Time Frame
52 Weeks
Title
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Description
The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54. Adjusted rates are reported.
Time Frame
Week 54
Title
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
Description
Adjusted mean values are all equal to zero.
Time Frame
Baseline to Week 54
Title
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
Description
The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.
Time Frame
Baseline through Week 54
Title
Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
Description
The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable). Adjusted means are reported.
Time Frame
Baseline to Week 54
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline to Week 54
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs)
Description
The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.
Time Frame
Baseline
Title
Serum Concentration of Astegolimab (MSTT1041A)
Time Frame
Weeks 26 and 54
Title
Percentage of Participants With Treatment-Emergent ADAs
Description
The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.
Time Frame
From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Allergy & Asthma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Del Sol Research Management
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Kern Allergy Med Clinic, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Allergy & Asthma Care Center of Southern California
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
CA Allergy & Asthma Med Grp; Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Jonathan Corren MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Office of Robert N Wolfe MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Advances in Medicine
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma & Allergy; Associates, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Western States Clinical Research, Inc
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Emerald Coast Research Associates
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Florida Premier Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Allergy & Asth Clin PC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Asthma & Allergy of Idaho
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Asthma, Allergy & Sinus Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Chesapeake Clinical Research Inc - CRN
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Genesis Clinical Research & Consulting, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Infinity Medical Research Inc
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Midwest Clinical Research LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Allergy and Asthma Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
American Health Research Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Allergy & Respiratory Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Integrity People Services Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Vital Prospects Clin Res Pc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Clinical Research Solutions PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Meharry Medical College; Clinical Trials Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
TTS Research
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Elliot J. Ginchansky, MD, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
077099
Country
United States
Facility Name
Metroplex Pulmonology & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Allergy & Asthma Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy Associates of Utah
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Commonwealth Clinical Research Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Washington Univ School of Med
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Fundacion Cidea
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
INAER
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
INSARES
City
Mendoza, Mendoza City
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Centro Respiratorio Quilmes
City
Quilmes
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Instituto Especialidades de la Salud Rosario
City
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas
City
Rosario
ZIP/Postal Code
S2000JKE
Country
Argentina
Facility Name
Centro Modelo de Cardiologia
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
CEMER Centro Medico de Enfermedades Respiratorias
City
Vicente López
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Private Practice Dr Jean Benoit Martinot
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Military Medical Academy HBAT
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Medical Centre Mladost Med 1 EOOD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
First MHAT; Clinic of Neurology
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
Fifth MHAT - Sofia EAD
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
National Multiprofile Hospital Tsar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center N.I. Pirogov EOOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Alitera - Med - Medical Center EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Medical Center Tara OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Aggarwal and Associates
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Cheema Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Inspiration Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Anil Dhar Professional Medicine Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
C.I.C. Mauricie
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
MediTrial s.r.o.
City
Jindřichův Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
EUC Klinika Ostrava a.s.
City
Ostrava-Poruba
ZIP/Postal Code
708 00
Country
Czechia
Facility Name
Ordinace pro tuberkulozu a respiracni nemoci
City
Strakonice
ZIP/Postal Code
38601
Country
Czechia
Facility Name
KASMED s.r.o.
City
Tabor
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Alergologie Teplice, s.r.o.
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Pneumologisches Forschungsinstitut Hohegeest
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
POIS Leipzig Gbr
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Greenlane Clinical Centre
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Medical Research Institute of New Zealand
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Clinica Internacional
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Abk Reuma Srl- Medicentro
City
Lima
ZIP/Postal Code
Lima 21
Country
Peru
Facility Name
Clinica Ricardo Palma; THORAX
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Instituto Peruano de Investigacion en Ciencias Medicas
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Hospital Santa Rosa Piura
City
Piura
ZIP/Postal Code
20001
Country
Peru
Facility Name
Centrum Medycyny Oddechowej Robert M. Mróz
City
Bialystok
ZIP/Postal Code
15-003
Country
Poland
Facility Name
Centrum Medyczne ALL-MED
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
City
Kraków
ZIP/Postal Code
31-637
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Specjalistyczna Poradnia Pulmonologiczna
City
Ostrow Wielkopolski
ZIP/Postal Code
63-400
Country
Poland
Facility Name
Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
City
Wroclaw
ZIP/Postal Code
53-301
Country
Poland
Facility Name
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
Facility Name
Theramed SRL
City
Brasov
ZIP/Postal Code
16
Country
Romania
Facility Name
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
Fundatia CardioPrevent
City
Timisoara
ZIP/Postal Code
300134
Country
Romania
Facility Name
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Clinical Emergency Hospital n.a.N.V. Soloviev
City
Yaroslavl
State/Province
Moskovskaja Oblast
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
LLC - ABC Medicina
City
Moscow
State/Province
Sankt Petersburg
ZIP/Postal Code
117574
Country
Russian Federation
Facility Name
City Hospital #5
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Ryazan State Medical University Named after I.P.Pavlov
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Clinic Reavita LLC
City
St. Petersburg
ZIP/Postal Code
194295
Country
Russian Federation
Facility Name
SHI Ctr Occupational Pathology
City
St. Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
St. Petersburg State Medical University n.a. I.P. Pavlov
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
City Hospital #40 of Resort Administrative District
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Tiervalei Trial Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
University of Cape Town Lung Institute; Lung Clinical Research
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
St Augustines Hospital; Infectoilogy
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Vawda Z.Fa Practice
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Aliwal Shoal Medical Center
City
Umkomaas
ZIP/Postal Code
4170
Country
South Africa
Facility Name
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58005
Country
Ukraine
Facility Name
Municipal institution; City hospital #1; Department of Therapy
City
Zaporizhzhia
State/Province
Kherson Governorate
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
City
Dnepropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Ukrainian State Institute of Medical and Social Problems of Disability
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Regional Phthisiology and Pulmonology Center
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #8
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
City Hospital #1
City
Mykolaiv
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Small Business Private Enterprise Medical Centre Pulse
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
33872652
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.
Results Reference
derived

Learn more about this trial

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

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