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

  • Asthma
Trial Status:

Completed

This trial runs in
Cities
  • abe
  • Bakersfield
  • Bellevue
  • Berlin
  • Białystok
  • Buenos Aires
  • Centennial
  • Cercado de Lima
  • chancay
  • Edmond
  • Frankfurt am Main
  • Hannover
  • Kraków
  • Ksawerów
  • Leipzig
  • Magdeburg
  • Mainz
  • Mar del Plata
  • McKinney
  • Mendoza
  • Miami
  • New Haven
  • Ostrowiec Świętokrzyski
  • Philadelphia
  • Poznań
  • Quilmes
  • San Isidro
  • San Miguel
  • San Miguel de Tucumán
  • Sosnowiec
  • Spartanburg
  • Toledo
  • Walnut Creek
  • Winter Park
  • Wrocław
  • Łódź
Trial Identifier:

NCT04092582 2019-000795-41 GB41149

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT04092582 , GB41149 , 2019-000795-41 Trial Identifier
      MTPS9579A, Placebo Treatments
      Asthma Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      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 >= 2 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, electronic cigarette (e-cigarette) user, former smoker with smoking history of > 10 pack-years, former e-cigarette user with an e-cigarette history of at least daily use for >=10 years, or unwilling to abstain from smoking and/or e-cigarette use 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 60 days after the final dose of MTPS9579A
      • Positive for TB at screening

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