Anti-KIT Barzolvolimab for Chronic Spontaneous Urticaria.

ABSTRACT:

Background

Chronic spontaneous urticaria (CSU) is characterized by mast cell (MC)-mediated wheals and/or angioedema without identifiable triggers and is driven by MC activation. Barzolvolimab-a monoclonal anti-KIT antibody-depletes MCs by inhibiting activation of KIT by stem cell factor. We evaluated multiple ascending doses in patients with CSU.

Methods

Phase 1b double-blind placebo-controlled trial (NCT04538794) in adults with moderate-to-severe (urticaria activity score over 7 days [UAS7] ≥ 16) antihistamine-refractory CSU treated with intravenous barzolvolimab for 12 weeks with a 12-week follow-up in four sequentially enrolled cohorts (randomized 4:1 barzolvolimab:placebo): 0.5 mg/kg, Q4W (n = 9); 1.5 mg/kg, Q4W (n = 8); 3 mg/kg, Q8W (n = 9); and 4.5 mg/kg, Q8W (n = 9).

SUBMITTER: Maurer M 

PROVIDER: S-EPMC12368744 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature