eligibility_summary
Adults 18-75 with diagnosed asthma >=12 mo, on medium-high ICS (>250 mcg fluticasone eq) + >=1 addl controller >=90 d (stable >=30), >=1 exacerbation in past yr, pre-BD FEV1 35-90% pred, ACQ-6 >=1.5. Exclude: severe exacerbation <30 d, other lung disease, current/quit <6 mo smoking/vaping or >10 pack-yrs, recent/suspected COVID-19, unresolved systemic infection, positive/indet. TB test, active/recent cancer (<5 y), major biologic reaction, recent helminth, HIV/immunodef., active HBV, HCV RNA+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study in adults with moderate-to-severe asthma testing rocatinlimab (AMG 451/KHK4083) vs placebo, given subcutaneously. Rocatinlimab is an afucosylated human IgG1 monoclonal antibody that targets OX40 (CD134). Mechanism: blocks OX40–OX40L costimulatory signaling and promotes ADCC-mediated depletion of OX40+ activated/effector-memory T cells, aiming to reduce T cell–driven airway inflammation and exacerbations. Cells/pathways targeted: OX40/TNFRSF4 pathway, activated CD4+ T cells (notably Th2 and other memory subsets). Downstream impact on type 2 cytokine axis (IL-4, IL-5, IL-13). Comparator: SC placebo.