a phase 2, dose ranging study assessing rocatinlimab in moderate-to-severe asthma

Conditions: Asthma

Summary: the primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.


Eligibility criteria:
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 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. * documented history of ≥ 1 asthma exacerbation in the past year prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ics (\> 250 μg fluticasone propionate or equivalent ics). * morning pre-bd fev1 ≥ 35% and ≤ 90% of predicted normal at the screening visit and day 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, 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.

Keywords: moderate to severe asthma rocatinlimab amg 451 khk4083