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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02918019




Registration number
NCT02918019
Ethics application status
Date submitted
27/09/2016
Date registered
28/09/2016
Date last updated
22/10/2019

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
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
Secondary ID [1] 0 0
2016-001549-13
Secondary ID [2] 0 0
GB39242
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Asthma Exacerbations
Timepoint [1] 0 0
Baseline up to Week 54
Secondary outcome [1] 0 0
Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 54
Timepoint [1] 0 0
Baseline up to Week 54
Secondary outcome [2] 0 0
Time to First Asthma Exacerbation
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Percentage of Participants with Improvement Increase in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score Greater than or Equal to (>/=) 0.5 Points
Timepoint [3] 0 0
Baseline up to Week 54
Secondary outcome [4] 0 0
Percentage of Participants With Improvement Decrease in Asthma Control Questionnaire-5 (ACQ-5) >/= 0.5 Points
Timepoint [4] 0 0
Baseline up to Week 54
Secondary outcome [5] 0 0
Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54
Timepoint [5] 0 0
Baseline up to Week 54
Secondary outcome [6] 0 0
Percentage of Weeks Without Patient-reported Asthma-related Night Time Awakenings
Timepoint [6] 0 0
Baseline up to Week 54
Secondary outcome [7] 0 0
Change From Baseline in Patient-reported Daytime Asthma Symptoms Severity at Week 54, as Measured by Asthma Daily Symptom Diary
Timepoint [7] 0 0
Baseline up to Week 54
Secondary outcome [8] 0 0
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
Timepoint [8] 0 0
Baseline up to Week 70
Secondary outcome [9] 0 0
Percentage of Participants With Anti-drug Antibodies (ADAs)
Timepoint [9] 0 0
Baseline up to Week 70
Secondary outcome [10] 0 0
Percentage of Participants With Treatment Emergent ADAs
Timepoint [10] 0 0
Baseline up to Week 70
Secondary outcome [11] 0 0
Serum Concentration of MSTT1041A
Timepoint [11] 0 0
Baseline up to Week 70

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autónoma de Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Mendoza, Mendoza City
Country [29] 0 0
Argentina
State/province [29] 0 0
Mendoza
Country [30] 0 0
Argentina
State/province [30] 0 0
Quilmes
Country [31] 0 0
Argentina
State/province [31] 0 0
Rosario
Country [32] 0 0
Argentina
State/province [32] 0 0
San Miguel de Tucuman
Country [33] 0 0
Argentina
State/province [33] 0 0
Vicente López
Country [34] 0 0
Belgium
State/province [34] 0 0
Bruxelles
Country [35] 0 0
Belgium
State/province [35] 0 0
Erpent
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Pleven
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Ruse
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Stara Zagora
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Veliko Tarnovo
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Czechia
State/province [44] 0 0
Jindrichuv Hradec
Country [45] 0 0
Czechia
State/province [45] 0 0
Olomouc
Country [46] 0 0
Czechia
State/province [46] 0 0
Ostrava-Poruba
Country [47] 0 0
Czechia
State/province [47] 0 0
Strakonice
Country [48] 0 0
Czechia
State/province [48] 0 0
Tabor
Country [49] 0 0
Czechia
State/province [49] 0 0
Teplice
Country [50] 0 0
Germany
State/province [50] 0 0
Geesthacht
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Koblenz
Country [53] 0 0
Germany
State/province [53] 0 0
Leipzig
Country [54] 0 0
Germany
State/province [54] 0 0
Mainz
Country [55] 0 0
Germany
State/province [55] 0 0
Münster
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Suwon City
Country [58] 0 0
New Zealand
State/province [58] 0 0
Auckland
Country [59] 0 0
New Zealand
State/province [59] 0 0
Wellington
Country [60] 0 0
Peru
State/province [60] 0 0
Lima
Country [61] 0 0
Peru
State/province [61] 0 0
Piura
Country [62] 0 0
Poland
State/province [62] 0 0
Bialystok
Country [63] 0 0
Poland
State/province [63] 0 0
Krakow
Country [64] 0 0
Poland
State/province [64] 0 0
Kraków
Country [65] 0 0
Poland
State/province [65] 0 0
Lodz
Country [66] 0 0
Poland
State/province [66] 0 0
Ostrow Wielkopolski
Country [67] 0 0
Poland
State/province [67] 0 0
Radom
Country [68] 0 0
Poland
State/province [68] 0 0
Tarnow
Country [69] 0 0
Poland
State/province [69] 0 0
Wroclaw
Country [70] 0 0
Romania
State/province [70] 0 0
Brasov
Country [71] 0 0
Romania
State/province [71] 0 0
Cluj-Napoca
Country [72] 0 0
Romania
State/province [72] 0 0
Craiova
Country [73] 0 0
Romania
State/province [73] 0 0
Timisoara
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Moskovskaja Oblast
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Sankt Petersburg
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Barnaul
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Kemerovo
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Moscow
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Novosibirsk
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Ryazan
Country [81] 0 0
Russian Federation
State/province [81] 0 0
St. Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Tomsk
Country [83] 0 0
South Africa
State/province [83] 0 0
Cape Town
Country [84] 0 0
South Africa
State/province [84] 0 0
Durban
Country [85] 0 0
South Africa
State/province [85] 0 0
Umkomaas
Country [86] 0 0
Ukraine
State/province [86] 0 0
Chernihiv Governorate
Country [87] 0 0
Ukraine
State/province [87] 0 0
Kherson Governorate
Country [88] 0 0
Ukraine
State/province [88] 0 0
KIEV Governorate
Country [89] 0 0
Ukraine
State/province [89] 0 0
Dnepropetrovsk
Country [90] 0 0
Ukraine
State/province [90] 0 0
Dnipropetrovsk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Ivano-Frankivsk
Country [92] 0 0
Ukraine
State/province [92] 0 0
Kharkiv
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kyiv
Country [94] 0 0
Ukraine
State/province [94] 0 0
Mykolaiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Odesa
Country [96] 0 0
Ukraine
State/province [96] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02918019
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications