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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 : Completed
First Posted : September 28, 2016
Results First Posted : December 28, 2022
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: MSTT1041A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 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
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. Reduction in Rate of Asthma Exacerbations [ Time Frame: Baseline to Week 54 ]

    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.

    Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.



Secondary Outcome Measures :
  1. Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline to Week 54 ]

    FEV1 measures how much air a person can exhale during the first second of a forced breath.

    Adjusted means are reported.


  2. Time to First Asthma Exacerbation [ Time Frame: 52 Weeks ]
    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.

  3. Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score [ Time Frame: Week 54 ]

    The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54.

    Adjusted rates are reported.


  4. Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy [ Time Frame: Baseline to Week 54 ]
    Adjusted mean values are all equal to zero.

  5. Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings [ Time Frame: Baseline through Week 54 ]
    The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.

  6. Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD) [ Time Frame: Baseline to Week 54 ]

    The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable).

    Adjusted means are reported.


  7. Percentage of Participants With Adverse Events [ Time Frame: Baseline to Week 54 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  8. Percentage of Participants With Anti-Drug Antibodies (ADAs) [ Time Frame: Baseline ]
    The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.

  9. Serum Concentration of Astegolimab (MSTT1041A) [ Time Frame: Weeks 26 and 54 ]
  10. Percentage of Participants With Treatment-Emergent ADAs [ Time Frame: From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54) ]
    The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.



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

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


Locations
Show Show 138 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] January 23, 2019
Statistical Analysis Plan  [PDF] April 5, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02918019    
Other Study ID Numbers: GB39242
2016-001549-13 ( EudraCT Number )
First Posted: September 28, 2016    Key Record Dates
Results First Posted: December 28, 2022
Last Update Posted: December 28, 2022
Last Verified: November 2022
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
Astegolimab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents