eligibility_summary
Adults ≥18 with ColdU or SD ≥3 months and wheals + itch/pain ≥6 weeks despite stable H1‑antihistamines (≤4×), positive TempTest (>4°C) or FricTest (≥3 pins), Hb≥11, Plt≥100k, WBC≥3k, ANC≥2k. CSU allowed if ColdU/SD dominant. Exclude: pregnancy, weight <40/>125 kg, other inducible urticaria/itch disorders, prior H2/LTRA/TCA, mAbs/JAK/BTK, or immunosuppressants, significant ECG, liver/bilirubin↑ or eCrCl<60, HIV/HBV/HCV/COVID, recent surgery/other trials, poor contraception, hypersensitivity, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06353971 evaluates briquilimab (JSP191), a subcutaneous monoclonal antibody against c‑KIT (CD117). Mechanism: it blocks stem cell factor (SCF) binding to c‑KIT, shutting down SCF/c‑KIT tyrosine kinase signaling, which depletes or functionally inhibits c‑KIT–dependent cells—most notably tissue mast cells—thereby reducing mast‑cell activation and mediator release (e.g., histamine, tryptase) that drive chronic inducible urticaria. Primary targets: skin mast cells, secondary on‑target effects may include hematopoietic stem/progenitor cells. Open-label, single ascending dose cohorts: 40, 120, 180 mg SC. Trial status: terminated (company priorities, not for safety).