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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02918019

Run by

Hoffmann-La Roche

People needed

517

Starts

2016-09-20

Expected to finish

2019-07-26

Last updated by the study team

2022-12-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Del Sol Research Management — Tucson, Arizona, United States
• Kern Allergy Med Clinic, Inc. — Bakersfield, California, United States
• Allergy & Asthma Care Center of Southern California — Long Beach, California, United States
• CA Allergy & Asthma Med Grp; Medical Group, Inc. — Los Angeles, California, United States
• Jonathan Corren MD, Inc. — Los Angeles, California, United States
• Office of Robert N Wolfe MD — Los Angeles, California, United States
• Advances in Medicine — Rancho Mirage, California, United States
• Allergy & Asthma Consultants — Redwood City, California, United States
• Bensch Research Associates — Stockton, California, United States
• Allergy and Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• IMMUNOe Research Centers — Centennial, Colorado, United States
• Asthma & Allergy; Associates, P.C. — Colorado Springs, Colorado, United States
• Western States Clinical Research, Inc — Wheat Ridge, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Emerald Coast Research Associates — Panama City, Florida, United States
• Florida Premier Research Institute — Winter Park, Florida, United States
• Atlanta Allergy & Asth Clin PC — Stockbridge, Georgia, United States
• Asthma & Allergy of Idaho — Twin Falls, Idaho, United States
• Asthma, Allergy & Sinus Center — Baltimore, Maryland, United States
• Chesapeake Clinical Research Inc - CRN — Baltimore, Maryland, United States
• Genesis Clinical Research & Consulting, LLC — Fall River, Massachusetts, United States
• Infinity Medical Research Inc — North Dartmouth, Massachusetts, United States
• Midwest Clinical Research LLC — St Louis, Missouri, United States
• The Allergy and Asthma Center — Bellevue, Nebraska, United States
• Alabama Allergy & Asthma — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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