eligibility_summary
Eligible: adults 18–54 with AD (AAD 2014) ≥12 months, inadequate response to medium+ potency TCS (±TCI), prior systemic AD therapy allowed after washout, vIGA-AD ≥3. Ineligible: biologics ≤12 wks/5 half-lives, ≤4 wks/5 half-lives systemic steroids/immunosuppressants, phototherapy, JAK inhibitors, ≤1 wk topical steroids, TCI, PDE4, other topical immunosuppressants/combos, live/attenuated vaccine ≤12 wks, meningococcal vax ≤1 yr, tetanus/diphtheria/pertussis vax ≤5 yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Rocatinlimab (AMG 451/KHK4083), a subcutaneous monoclonal antibody targeting OX40 (CD134). Mechanism: inhibits OX40–OX40L costimulatory signaling and depletes OX40-expressing activated effector/memory T cells, dampening T cell–driven (notably type 2/Th2) inflammation in atopic dermatitis. Comparator: placebo. Cells/pathways targeted: activated CD4+ T cells (including Th2 and tissue-resident memory subsets) expressing OX40, the OX40/TNFRSF4 costimulatory axis, leading to reduced T cell activation and downstream type 2 inflammatory signaling. Purpose: evaluate impact on vaccine antibody responses (tetanus and meningococcal) after 24 weeks in adults with moderate-to-severe AD.