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

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ClinicalTrials.gov Identifier: NCT02918019

Recruitment Status : Active, not recruiting

First Posted : September 28, 2016

Last Update Posted : July 19, 2018

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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

Secondary Outcome Measures :

Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 54 [ Time Frame: Baseline, Week 54 ]
Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54 [ Time Frame: Baseline, Week 54 ]
Percentage of Weeks Without Patient-reported Asthma-related Night Time Awakenings [ Time Frame: Baseline up to Week 54 ]
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 ]
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 ]
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 70 ]
Percentage of Participants With Anti-drug Antibodies (ADAs) [ Time Frame: Baseline up to Week 70 ]
Percentage of Participants With Treatment Emergent ADAs [ Time Frame: Baseline up to Week 70 ]
Serum Concentration of MSTT1041A [ Time Frame: Baseline up to Week 70 ]
Time to First Asthma Exacerbation [ Time Frame: 52 Weeks ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918019

Show 176 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

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 Key Record Dates
Last Update Posted:	July 19, 2018
Last Verified:	July 2018

Additional relevant MeSH terms:


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

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