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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Reduction in Rate of Asthma Exacerbations
Timepoint [1] 0 0
Baseline to Week 54
Secondary outcome [1] 0 0
Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [1] 0 0
Baseline to Week 54
Secondary outcome [2] 0 0
Time to First Asthma Exacerbation
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
Timepoint [3] 0 0
Week 54
Secondary outcome [4] 0 0
Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
Timepoint [4] 0 0
Baseline to Week 54
Secondary outcome [5] 0 0
Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
Timepoint [5] 0 0
Baseline through Week 54
Secondary outcome [6] 0 0
Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
Timepoint [6] 0 0
Baseline to Week 54
Secondary outcome [7] 0 0
Percentage of Participants With Adverse Events
Timepoint [7] 0 0
Baseline to Week 54
Secondary outcome [8] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs)
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Serum Concentration of Astegolimab (MSTT1041A)
Timepoint [9] 0 0
Weeks 26 and 54
Secondary outcome [10] 0 0
Percentage of Participants With Treatment-Emergent ADAs
Timepoint [10] 0 0
From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)

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
Sex
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
20/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2019
Sample size
Target
Accrual to date
Final
517
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Mendoza, Mendoza City
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Sofia
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Odesa
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Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02918019