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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
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Trial 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
All
≥18 Years & ≤ 75 Years
No
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 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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For the latest version of this information please go to www.forpatients.roche.com