A study to compare different doses of MSTT1041A with a “placebo” – in patients with severe asthma

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

Respiratory Disorder
Asthma

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Basic Details

Gender

All

Age

≥18 Years & ≤ 75 Years

Healthy Volunteers

Sponsor Hoffmann-La Roche

Phase Phase 2

Study Identifier NCT02918019, GB39242, 2016-001549-13

This clinical trial was done to study a new medicine called, “MSTT1041A”, for the treatment of patients with severe asthma. This study was done to find the dose of MSTT1041A that was effective for reducing the number of asthma exacerbations. Other questions that researchers had included finding the dose of MSTT1041A that was effective for improving other symptoms for asthma patients; time it took for MSTT1041A to be distributed in the body; whether MSTT1041A was safe for asthma patients; and whether MSTT1041A caused the immune system to make antibodies against this medicine. There were 502 patients with asthma who took part in this study at 182 study centers in 15 countries.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Study Identifier NCT02918019, GB39242, 2016-001549-13

Condition 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 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.

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 75 Years

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to compare different doses of MSTT1041A with a “placebo” – in patients with severe asthma

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS_GB39242_ZENYATTA_final results_April2020_Afrikaans_South Africa (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Bulgarian (PDF, 0.2 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Czech (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Dutch_Belgium (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_English (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_French_Belgium (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_French_Canada (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_German (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Korean (PDF, 0.2 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Polish (PDF, 0.2 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Romanian (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Russian (PDF, 0.2 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Spanish_Latin America (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Spanish_US (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Ukrainian (PDF, 0.2 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Xhosa_South Africa (PDF, 0.1 MB)

LPS_GB39242_ZENYATTA_final results_April2020_Zulu_South Africa (PDF, 0.1 MB)

What is Clinical Research?

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A study to compare different doses of MSTT1041A with a “placebo” – in patients with severe asthma

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com