Barzolvolimab Demonstrates Safety and Clinically Meaningful Activity as Early as Two Weeks in Moderate to Severe Prurigo Nodularis

Authors

• Martin Metz
• Sonja Stander
• Ali Moiin, Corewell Health East
• Leigh Nattkemper
• Bradley Bloom
• Diego Alvarado
• Mark Rogalski
• Yufang Lu
• Marcus Maurer
• Gil Yosipovitch

Document Type

Conference Proceeding

Publication Date

9-2024

Publication Title

Journal of the American Academy of Dermatology

Abstract

Introduction: Mast cells (MC) may contribute to chronic itch and neuroinflammation in prurigo nodularis (PN). Barzolvolimab (anti-KIT monoclonal antibody) depletes MC. This Phase 1b study (NCT04944862), assesses safety/tolerability, and clinical effect of barzolvolimab in patients with moderate to severe PN. Methods: Patients were randomized to receive a single IV dose of barzolvolimab 1.5 mg/kg, 3.0 mg/kg, or placebo, and followed for 24 weeks. Primary endpoint was safety. Clinical activity assessments included Worst Itch Numeric Rating Scale (WINRS), and Investigator Global Assessment (IGA). Results: Twenty-four patients were enrolled with mean WI-NRS of 8.6 and mean IGA of 3.3 at baseline. Barzolvolimab was generally well tolerated. No adverse event was reported in more than one barzolvolimab treated patient. One patient (3.0 mg/kg) had anaphylaxis that resolved without sequelae. Two weeks after treatment, mean reduction in WI-NRS was 19% (1.5 mg/kg), 33% (3.0 mg/kg), and 14% (placebo). Mean reduction in WI-NRS at 8 weeks was 32% (1.5 mg/kg), 46% (3.0 mg/kg) and 30% (placebo). Clear or almost clear (IGA 0%) was achieved by 29% in 3.0 mg/kg dose while 1.5 mg/kg and placebo had no responders. Clinical activity was associated with serum tryptase reduction, which was sustained at 3.0 mg/kg dose. Conclusion: A single dose of barzolvolimab was generally well tolerated and accompanied by clinically meaningful improvements in itch and PN lesion healing observed as early as 2 weeks. These early data support an important role for MC in the pathophysiology of PN and warrant further study of barzolvolimab for treatment of PN.

Volume

91

Issue

3 Suppl

First Page

AB140

Last Page

AB140

Recommended Citation

Metz M, Stander S, Moiin A, Nattkemper L, Bloom B, Alvarado D, et al. Barzolvolimab demonstrates safety and clinically meaningful activity as early as two weeks in moderate to severe prurigo nodularis. J Am Acad Dermatol. 2024 Sep;91(3 Suppl):AB140. doi:10.1016/j.jaad.2024.07.562

Comments

American Academy of Dermatology Annual Meeting, March 8-12, 2024, San Diego, CA

DOI

10.1016/j.jaad.2024.07.562