A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
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| ClinicalTrials.gov Identifier: NCT02918019 |
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Recruitment Status :
Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : January 9, 2019
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MSTT1041A 210 mg
Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
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Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807 |
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Experimental: MSTT1041A 490 mg
Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
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Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807 |
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Experimental: MSTT1041A 70 mg
Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
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Drug: MSTT1041A
MSTT1041A will be administered as subcutaneous injections.
Other Name: RO7187807 |
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Placebo Comparator: Placebo
Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
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Drug: Placebo
Placebo matched with MSTT1041A. |
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 ]
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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
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
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| 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: | January 9, 2019 |
| Last Verified: | January 2019 |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |