Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02918019
Registration number
NCT02918019
Ethics application status
Date submitted
27/09/2016
Date registered
28/09/2016
Date last updated
28/12/2022
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2016-001549-13
Query!
Secondary ID [2]
0
0
GB39242
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - MSTT1041A
Treatment: Drugs - Placebo
Experimental: MSTT1041A 210 mg - Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
Experimental: MSTT1041A 490 mg - Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
Experimental: MSTT1041A 70 mg - Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
Placebo Comparator: Placebo - Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Treatment: Drugs: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Treatment: Drugs: Placebo
Placebo matched with MSTT1041A.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Reduction in Rate of Asthma Exacerbations
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline to Week 54
Query!
Secondary outcome [1]
0
0
Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Query!
Assessment method [1]
0
0
FEV1 measures how much air a person can exhale during the first second of a forced breath.
Adjusted means are reported.
Query!
Timepoint [1]
0
0
Baseline to Week 54
Query!
Secondary outcome [2]
0
0
Time to First Asthma Exacerbation
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
52 Weeks
Query!
Secondary outcome [3]
0
0
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 54
Query!
Secondary outcome [4]
0
0
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
Query!
Assessment method [4]
0
0
Adjusted mean values are all equal to zero.
Query!
Timepoint [4]
0
0
Baseline to Week 54
Query!
Secondary outcome [5]
0
0
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline through Week 54
Query!
Secondary outcome [6]
0
0
Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline to Week 54
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Adverse Events
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline to Week 54
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Anti-Drug Antibodies (ADAs)
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline
Query!
Secondary outcome [9]
0
0
Serum Concentration of Astegolimab (MSTT1041A)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Weeks 26 and 54
Query!
Secondary outcome [10]
0
0
Percentage of Participants With Treatment-Emergent ADAs
Query!
Assessment method [10]
0
0
The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.
Query!
Timepoint [10]
0
0
From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/09/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
517
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oklahoma
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Rhode Island
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Mendoza, Mendoza City
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Mendoza
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Quilmes
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Rosario
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
San Miguel de Tucuman
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Vicente López
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Bruxelles
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Erpent
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Pleven
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Ruse
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Sofia
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Stara Zagora
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Veliko Tarnovo
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Ontario
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Quebec
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Jindrichuv Hradec
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Ostrava-Poruba
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Strakonice
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Tabor
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Teplice
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Geesthacht
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Leipzig
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Mainz
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Münster
Query!
Country [51]
0
0
Korea, Republic of
Query!
State/province [51]
0
0
Seoul
Query!
Country [52]
0
0
New Zealand
Query!
State/province [52]
0
0
Auckland
Query!
Country [53]
0
0
New Zealand
Query!
State/province [53]
0
0
Wellington
Query!
Country [54]
0
0
Peru
Query!
State/province [54]
0
0
Lima
Query!
Country [55]
0
0
Peru
Query!
State/province [55]
0
0
Piura
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Bialystok
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Krakow
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Kraków
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Lodz
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Ostrow Wielkopolski
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Radom
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Tarnow
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Wroclaw
Query!
Country [64]
0
0
Romania
Query!
State/province [64]
0
0
Brasov
Query!
Country [65]
0
0
Romania
Query!
State/province [65]
0
0
Cluj-Napoca
Query!
Country [66]
0
0
Romania
Query!
State/province [66]
0
0
Craiova
Query!
Country [67]
0
0
Romania
Query!
State/province [67]
0
0
Timisoara
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Moskovskaja Oblast
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Sankt Petersburg
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Barnaul
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Kemerovo
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Moscow
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Novosibirsk
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Ryazan
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
St. Petersburg
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Tomsk
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
Cape Town
Query!
Country [78]
0
0
South Africa
Query!
State/province [78]
0
0
Durban
Query!
Country [79]
0
0
South Africa
Query!
State/province [79]
0
0
Umkomaas
Query!
Country [80]
0
0
Ukraine
Query!
State/province [80]
0
0
Chernihiv Governorate
Query!
Country [81]
0
0
Ukraine
Query!
State/province [81]
0
0
Kherson Governorate
Query!
Country [82]
0
0
Ukraine
Query!
State/province [82]
0
0
KIEV Governorate
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Dnepropetrovsk
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Dnipropetrovsk
Query!
Country [85]
0
0
Ukraine
Query!
State/province [85]
0
0
Ivano-Frankivsk
Query!
Country [86]
0
0
Ukraine
Query!
State/province [86]
0
0
Kharkiv
Query!
Country [87]
0
0
Ukraine
Query!
State/province [87]
0
0
Kyiv
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Mykolaiv
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Odesa
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Vinnytsya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02918019
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02918019
Download to PDF