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

  • Asthma
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • New Zealand
  • Peru
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Ukraine
  • United States
Trial Identifier:

NCT02918019 2016-001549-13 GB39242

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02918019 , GB39242 , 2016-001549-13 Trial Identifier
      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers

      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.

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02918019 , GB39242 , 2016-001549-13 Trial Identifier
      MSTT1041A, Placebo Treatments
      Asthma Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No 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

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now