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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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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/study/NCT02918019
Trial related presentations / publications
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02918019