A Phase 2 Study Assessing Rocatinlimab in uncontrolled Asthma patients.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Uncontrolled Asthma

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Inclusion Criteria:

1. Participants must be between the ages of 18 and 75.
2. Asthma diagnosed by a physician for greater than or equal to 12 months prior to the screening visit.
3. Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as greater than 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist [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.
4. Documented history of greater than or equal to 1 asthma exacerbation in the past year, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 μg fluticasone propionate or equivalent ICS).
5. Morning pre-BD FEV1 greater than or equal to 40% and less than or equal to 80% of predicted normal at the screening visit and day 1 pre-randomization visits.
6. ACQ-6 score greater than or equal to 1.5 at the day 1 pre randomization visit.

Exclusion Criteria:

1. 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.
2. Any clinically important pulmonary disease other than asthma.
3. Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of greater than 10 pack-years.
4. 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.
5. 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.
6. Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
7. Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
8. History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
9. 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.
10. 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.
11. Active and non-virally suppressed hepatitis B infection at initial screening,
12. Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.