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

Inclusion Criteria:

• Participants must be between the ages of 18 and 75.

• Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.

• Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination withat least 1 additional controller medication (eg, LABA, leukotriene receptorantagonist [LTRA], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit witha stable dose for at least 30 days prior to the screening visit.

• Documented history of ≥ 1 asthma exacerbation in the past year prior to thescreening visit, with at least 1 exacerbation during treatment with medium-dose tohigh doses of ICS (> 250 μg fluticasone propionate or equivalent ICS).

• Morning pre-BD FEV1 ≥ 35% and ≤ 90% of predicted normal at the screening visit andday 1 pre-randomization visits.

• ACQ-6 score ≥ 1.5 at the day 1 pre randomization visit.

Exclusion Criteria:

• Asthma exacerbation that results in emergency treatment or hospitalization, ortreatment with systemic steroids at any time from 30 days prior to the day 1 prerandomization visit.

• Any clinically important pulmonary disease other than asthma.

• Current smoker, including active vaping of any products and/or marijuana, or formersmoker with cessation within 6 months of screening, or history of > 10 pack-years.

• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during thescreening period including known history of COVID-19 infection within 4 weeks priorto Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO)secondary to COVID-19 within 3 months prior to screening; participants with COVID-19infection who have not yet sufficiently recovered to participate in the proceduresof a clinical trial.

• Active chronic or acute infection requiring treatment with systemic antibiotics,antiviral, antiparasitic, antiprotozoal, or antifungals which has not completelyresolved, or for which therapy has not been completed, within 4 weeks before day 1pre-randomization visit.

• Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.

• Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferativedisorder; or a history of any of these conditions within 5 years prior to informedconsent

• History of major immunologic reaction to any other biologic product or any excipientof rocatinlimab.

• Diagnosis of a helminth parasitic infection within 6 months prior to day 1pre-randomization visit that had not been treated with or had failed to respond tostandard of care therapy.

• Evidence of human immunodeficiency virus (HIV) infection or positive for HIVantibodies at screening or current acquired, common variable or inherited, primaryor secondary immunodeficiency.

• Active and non-virally suppressed hepatitis B infection at initial screening,

• Positive for hepatitis C virus (HCV) antibody at screening with confirmed positiveHCV RNA.