A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Exclusion Criteria

• •Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
• •Any clinically important pulmonary disease other than asthma.
• •Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of \> 10 pack-years.
• •Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
• •Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
• •Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
• •Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
• •History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
• •Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
• •Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
• •Active and non-virally suppressed hepatitis B infection at initial screening,
• •Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.