A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Condition: Asthma
MeSH terms: Asthma
Intervention: MTPS9579A; Placebo
Intervention description: MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.; Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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