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

Study Description

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Brief Summary:

This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study 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 or disease	Intervention/treatment	Phase
Asthma	Drug: MSTT1041A; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	September 20, 2016
Estimated Primary Completion Date :	September 19, 2019
Estimated Study Completion Date :	September 19, 2019

Arms and Interventions

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Arm	Intervention/treatment
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 Name: 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 Name: 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 Name: 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.

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants With Asthma Exacerbations [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :

1. Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 54 [ Time Frame: Baseline, Week 54 ]
2. Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54 [ Time Frame: Baseline, Week 54 ]
3. Percentage of Weeks Without Patient-reported Asthma-related Night Time Awakenings [ Time Frame: Baseline up to Week 54 ]
4. Change From Baseline in Patient-reported Daytime Asthma Symptoms Severity at Week 54, as Measured by Asthma Daily Symptom Diary [ Time Frame: Baseline, Week 54 ]
5. Percentage of Participants With Improvement From Randomization Visit in St. George's Respiratory Questionnaire (SGRQ) Score, Define as Decrease of Greater Than or Equal to (>/=) 4 Points [ Time Frame: Baseline up to Week 54 ]
6. Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 70 ]
7. Percentage of Participants With Anti-drug Antibodies (ADAs) [ Time Frame: Baseline up to Week 70 ]
8. Percentage of Participants With Treatment Emergent ADAs [ Time Frame: Baseline up to Week 70 ]
9. Serum Concentration of MSTT1041A [ Time Frame: Baseline up to Week 70 ]
10. Time to First Asthma Exacerbation [ Time Frame: 52 Weeks ]
11. Percentage of Participants With Improvement From Randomization Visit in Asthma Control Questionnaire-5 (ACQ-5), Defined as Decrease of Greater Than or Equal to (>/=) 0.5 Points [ Time Frame: Baseline Up to Week 54 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 176 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02918019 History of Changes
Other Study ID Numbers:	GB39242; 2016-001549-13 ( EudraCT Number )
First Posted:	September 28, 2016
Last Update Posted:	April 17, 2018
Last Verified:	April 2018

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases