eligibility_summary
Adults ≥18 with CSU ≥6 months and itch/hives ≥8 weeks despite H1 antihistamines, cohorts 1–7 also failed/intolerant to omalizumab, cohorts 8–9 may be naïve/exposed. Need UAS7 ≥16, ISS7 ≥8, stable H1 dose (≤4×), Hgb ≥11, Plt ≥100k, WBC ≥3k, ANC ≥2k, and diary. Exclude: pregnancy, inducible urticaria, confounding skin/angioedema disorders, anaphylaxis, recent H2/LTRA/TCA, biologics/JAKs/immunosuppressants, significant ECG/LFTs, eCrCl <60, HIV/HBV/HCV/COVID, major surgery, contraception noncompliance, recent trial, hypersensitivity, other risks/site ties.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Briquilimab (JSP191), a humanized monoclonal antibody drug administered subcutaneously, versus placebo. Mechanism of action: Briquilimab binds c-Kit (CD117), the receptor for stem cell factor (SCF), blocking SCF/c-Kit signaling and depleting or inhibiting c-Kit–expressing cells, especially tissue mast cells. Therapeutic intent in CSU: reduce mast-cell numbers/activation and mediator release (histamine, tryptase) to lessen hives and itch. Targets/pathways: mast cells (cutaneous/systemic), c-Kit/CD117 pathway, SCF signaling, downstream effects measured via serum tryptase and allergic skin reactivity. Population: adults with CSU uncontrolled on H1 antihistamines and/or omalizumab. Study: Phase 1b/2a dose-escalation with randomized, double-blind, placebo-controlled parts to assess safety, PK/PD, and preliminary efficacy.