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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
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE September 20, 2016
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Rate of Asthma Exacerbations [ Time Frame: Baseline up to Week 54 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
Percentage of Participants With Asthma Exacerbations [ Time Frame: 52 Weeks ]
Change History Complete list of historical versions of study NCT02918019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 54 [ Time Frame: Baseline up to Week 54 ]
  • Time to First Asthma Exacerbation [ Time Frame: 52 Weeks ]
  • Percentage of Participants with Improvement Increase in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score Greater than or Equal to (>/=) 0.5 Points [ Time Frame: Baseline up to Week 54 ]
  • Percentage of Participants With Improvement Decrease in Asthma Control Questionnaire-5 (ACQ-5) >/= 0.5 Points [ Time Frame: Baseline up to Week 54 ]
  • Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54 [ Time Frame: Baseline up to 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 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • Change From Baseline in pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 14, 26, and 54 [ Time Frame: Baseline, Week 14, 26, 54 ]
  • Change From Baseline in Patient-reported use of Short-acting Rescue Therapy at Week 54 [ Time Frame: Baseline, Week 54 ]
  • Change From Baseline in Patient-reported Asthma-related Night Time Awakenings at Week 54 [ Time Frame: Baseline, Week 54 ]
  • Change From Baseline in Patient-reported Asthma Symptoms Severity at Week 54 [ Time Frame: Baseline, Week 54 ]
  • Percentage of Participants With Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ[S]) Score, Define as Decrease of Greater Than or Equal to (>/=) 0.5 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 72 ]
  • Percentage of Participants With Anti-therapeutic Antibodies (ATAs) [ Time Frame: Baseline up to Week 72 ]
  • Percentage of Participants With Treatment Emergent ATAs [ Time Frame: Baseline up to Week 72 ]
  • Serum Concentration of MSTT1041A [ Time Frame: Baseline up to Week 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: MSTT1041A
    MSTT1041A will be administered as subcutaneous injections.
    Other Name: RO7187807
  • Drug: Placebo
    Placebo matched with MSTT1041A.
Study Arms  ICMJE
  • Experimental: MSTT1041A 210 mg
    Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
    Intervention: Drug: MSTT1041A
  • Experimental: MSTT1041A 490 mg
    Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
    Intervention: Drug: MSTT1041A
  • Experimental: MSTT1041A 70 mg
    Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
    Intervention: Drug: MSTT1041A
  • Placebo Comparator: Placebo
    Participants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
517
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
500
Actual Study Completion Date  ICMJE July 26, 2019
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Belgium,   Canada,   Czechia,   Germany,   Korea, Republic of,   New Zealand,   Peru,   Poland,   Romania,   Russian Federation,   South Africa,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02918019
Other Study ID Numbers  ICMJE GB39242
2016-001549-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP