A Phase 2, Double-blind, Placebo-controlled, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Prior treatment

• Subjects who experience an 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.
• 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; subjects 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.
• Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma).
• 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.

Other illness

• 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, defined as detectable hepatitis B DNA polymerase chain reaction (PCR) test in a subject with detectable hepatitis B Surface Antigen (HBsAg) and/or antibodies to hepatitis B core (anti HBc). Subjects with detectable HBsAg are required to be virally suppressed with an approved hepatitis B antiviral therapy during the study. For sites and subjects participating in the European Economic Area,
• Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.
• 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.

Lab values

• Any clinically important pulmonary disease other than asthma (eg, active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg Strauss syndrome, hypereosinophilic syndrome.
• Positive or indeterminate QuantiFERON GOLD from central laboratory at screening. If QuantiFERON GOLD from central laboratory is indeterminate it may be repeated once. If repeat test remains indeterminate or is positive the subject is excluded from participation. Exception: A positive or indeterminate QuantiFERON test is allowed if ALL of the following are present at day 1 pre-randomization: Documented history of a completed course of adequate prophylaxis (completed treatment for active or latent tuberculosis per local standard of care prior to start of investigational product.) No known exposure to a case of active TB after most recent prophylaxis. No evidence of active TB on chest radiograph obtained within 3 months prior to day 1 pre-randomization visit. Prior to enrollment, the participant must obtain approval from a TB specialist or an infectious diseases specialist.
• History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.

• Subjects must be between the ages of 18 and 75 inclusive or of legal age within the specific country( if different) at the time of signing the informed consent.
• Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.
• Existing therapy with medium-dose to high-dose ICS (fluticasone propionate daily or equivalent ICS) with at least 1 additional controller medication (eg, LABA, 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 with a stable dose for at least 30 days prior to the screening visit. To be classified as being on medium-dose ICS, the subjects will be on a pre-determined total daily dose (sum of all ICS) of fluticasone propionate dry powder inhaler (DPI) equivalent. To be classified as being on high-dose ICS, the subjects will be on a pre-determined total daily dose of fluticasone propionate DPI equivalent. Classification of ICS doses (medium or high) will be based upon the GINA guidelines ICS classification table (GINA, 2022).