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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MSTT1041A 210 mg 		Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
  • Drug: MSTT1041A
    MSTT1041A will be administered as subcutaneous injections.
    Other names:
    • RO7187807
Experimental
MSTT1041A 490 mg 		Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
  • Drug: MSTT1041A
    MSTT1041A will be administered as subcutaneous injections.
    Other names:
    • RO7187807
Experimental
MSTT1041A 70 mg 		Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
  • Drug: MSTT1041A
    MSTT1041A will be administered as subcutaneous injections.
    Other names:
    • RO7187807
Placebo Comparator
Placebo 		Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
  • Drug: Placebo
    Placebo matched with MSTT1041A.

More Details

Status
Completed
Sponsor
Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.