Asthma
Conditions
Interventions
Treatment Arm A: Placebo
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
Treatment Arm B: Dose 1 Rocatinlimab
Participants will receive dose 1 roc
Sponsors
Jared Silver
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be between the ages of 18 and 75. 2. Asthma diagnosed by a physician for >= 12 months prior to the screening visit. 3. Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 microgram 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 >= 1 asthma exacerbation in the past year, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 microgram fluticasone propionate or equivalent ICS). 5. Morning pre-BD FEV1 >= 35% and = 1.5 at the day 1 pre randomization visit.
Exclusion criteria
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 > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Annualized Asthma Exacerbation Rate (AAER) 2. Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) 3. Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 4. Change From Baseline in Pre-BD FEV1 5. Change From Baseline in Asthma Symptom Diary (ASD) Score 6. Number of Participant Achieving ACQ-6 Response at Week 48 7. Change From Baseline in ACQ-6 8. Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score 9.Number of Participants Achieving AQLQ (S) Response at Week 48 10. Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period 11. Time to First Asthma Exacerbation Event 12. Time to First CompEx Event 13. Number of Participants with a CompEx Event During the Double Blinded Treatment Period 14. Annualized Rate of CompEx Events 15. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels 16. Serum Rocatinlimab Concentrations 17. Trough Concentration (Ctrough) of Rocatinlimab 18. Number of Participants with Treatment-emergent Adverse Events 19. Number of Participants with Serious Adverse Events 20. Number of Participants with Anti-rocatinlimab Antibody Formation | — |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Hong Kong, Hungary, Japan, Mexico, Peru, Poland, Romania, South Korea, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed