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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller

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ClinicalTrials.gov Identifier: NCT04092582
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE October 31, 2019
Estimated Primary Completion Date February 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Time to First CompEx Event [ Time Frame: Randomization visit [Week 2] to end of treatment [Week 50] ]
A composite endpoint is defined as time from randomization to first asthma exacerbation or diary worsening
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04092582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Rate of Asthma Exacerbations, as Assessed by the Investigator [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  • Time to First Asthma Exacerbation [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  • Absolute and Relative Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: From randomization visit [Week 2] to end of treatment [Week 50] ]
  • Absolute and Relative Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Randomization [Week 2] to end of treatment [Week 50] ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately Week 58 ]
  • Serum Concentration of MTPS9579A [ Time Frame: Days 15, 23, 44, 72, 100, 156, 212, 268, 352 ]
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) [ Time Frame: Up to week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Official Title  ICMJE A Phase IIa, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Brief Summary This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: MTPS9579A
    MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.
  • Drug: Placebo
    Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Study Arms  ICMJE
  • Experimental: MTPS9579A
    Intervention: Drug: MTPS9579A
  • Placebo Comparator: Placebo
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2022
Estimated Primary Completion Date February 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented physician-diagnosed asthma for at least 12 months prior to screening
  • Treatment with asthma controller therapy (daily ICS [fluticasone propionate or equivalent] and at least one additional controller therapy [LABA, LAMA, LTM/LTRA]) for >= 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the study
  • Documented history of >= 1 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy
  • For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma
  • History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD
  • Current smoker, former smoker with smoking history of > 10 pack-years, or unwilling to abstain from smoking from the time of consent through the completion of the study
  • History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
  • Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 42 days after the final dose of MTPS9579A
  • Positive for TB at screening
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: Reference Study ID Number: GB41149 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Peru,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092582
Other Study ID Numbers  ICMJE GB41149
2019-000795-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date November 2019

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