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

NCT02918019

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Asthma

Interventions: MSTT1041A, Placebo

Countries: United States, Argentina, Belgium, Bulgaria, Canada, Czechia, Germany, New Zealand

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (138)
  • Birmingham, Alabama, United States
  • Tucson, Arizona, United States
  • Bakersfield, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Rancho Mirage, California, United States
  • Redwood City, California, United States
  • Stockton, California, United States
  • Walnut Creek, California, United States
  • Centennial, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • New Haven, Connecticut, United States
  • Panama City, Florida, United States
  • Winter Park, Florida, United States
  • Stockbridge, Georgia, United States
  • Twin Falls, Idaho, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Fall River, Massachusetts, United States
  • North Dartmouth, Massachusetts, United States
  • St Louis, Missouri, United States
  • Bellevue, Nebraska, United States
  • The Bronx, New York, United States
  • Charlotte, North Carolina, United States
  • Canton, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Tulsa, Oklahoma, United States
  • + 108 more on CT.gov