Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age over 18-75 years of age
• Stable asthma medications: No change in asthma medications for the past 2 months
  • Use of medium or high dose inhaled corticosteroids (ICS) AND
  • Use of an additional asthma controller medication
• Baseline poor or uncontrolled asthma, defined as meeting at least one of the following:
  • FEV1 < 80% predicted (for adults ≥ 18)
  • Poor asthma control – Asthma Control Questionnaire (ACQ-6) Score ≥ 1.5.
  • Participants on medium to high dose ICS at screening
• Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence) if testing was performed under either the 2017 ERS technical standard or the 1999 ATS Guidelines or outside studies, provided that full sets of flow volume loops have been reviewed and approved by the site PI.  These criteria are defined as:
  • An increase in FEV1 ≥ 8% after up to 8 puffs of albuterol OR
  • Positive methacholine defined as PC20 ≤ 25 mg/mL
• Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

• Current participation in an interventional trial (e.g. drugs, diets, etc.)
• Currently on an asthma biologic (Table 1C) or having been on biologic within 3 months of screening (a patient currently on a biologic may choose to wash out of that medication for 3 months and be screened.)
• Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater)
• Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
• Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma. 
• Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®)
• Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy
• Underwent a bronchial thermoplasty within the last two years
• Born before 30 weeks of gestation
• Uncontrolled hypertension, defined as systolic blood pressure > 160 mm/Hg or diastolic blood pressure > 100 mm/Hg
• History of malignancy except non-melanoma skin cancer within the last five years
• History of smoking
  • If < 45 years old: Smoked for ≥ 5 pack-years
  • If ≥ 45 years old: Smoked ≥ 10 pack years
  • Smoking equivalent pack years.  One pack of cigarettes a day for 1 year is equivalent to:
    • 1 cigar or pipe per day for 1 year
    • Smoked hookah or shisha =1 session per day for 1 year
    • Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year
    • 1 use of marijuana per day for 1 year
• Active use of any inhalant >1 time per month in the past year
  • Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods >1 time per month in the past year.
  • Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc.
  • Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods, etc.
  • Any form of inhaled marijuana, including smoking marijuana leaves or inhaling THC via e-cigarette or device
• Substance abuse within the last year
• Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation. Medically acceptable birth control/abstinence is defined as:
  • Career, lifestyle, or sexual orientation precludes intercourse with a male partner
  • For those in a monogamous relationship that precludes sexual activity with other partners, one of the sexual partners has been sterilized by vasectomy (in males) or hysterectomy and/or bilateral salpingo-oophorectomy (in females)
  • Use of highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (https://www.cdc.gov/reproductivehealth/contraception/index.htm). Contraception should be used for at least 1 month prior to start of study treatment, throughout study participation and for an additional 16 weeks after the end of the final test treatment.  For females of child-bearing potential, pregnancy tests will be given prior to study enrollment and at each clinic visit.
• Requirement for daily systemic corticosteroids at the time of screening.
• Respiratory infection within 1 month of screening
• Intubation for asthma in the last 12 months
• Any clinically significant abnormal findings in the history, physical examination, vital signs, prior electrocardiogram, hematology, or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete the entire duration of the study. (This includes a known parasitic infection).
• BMI > 38
• Allergic to any of the drugs, biologics or chemicals used in this study
• Enrollment will be delayed or cancelled for any subject reporting an asthma exacerbation. Participants can also be excluded for their safety as determined by the investigator

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/1/204. Questions regarding updates should be directed to the study team contact.