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A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
428 patients around the world
Available in Chile, United States
Amgen
3Research sites
428Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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 to high doses of inhaled corticosteroids (ICS) defined as > 250 µg fluticasone propionate or equivalent ICS in combination with at least 1 additional controller 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 with at least 1 exacerbation during treatment with medium to high doses of ICS > 250 μg fluticasone propionate or equivalent ICS.Morning pre-BD FEV1 ≥ 40% and ≤ 80% 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.
- 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.
Sites
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Recruiting
Centro de Investigación del Maule - Talca
Recruiting
Icegclinic Research & Care
Recruiting
SponsorAmgen
Conditions
Asthma
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06376045
