A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria

Summary

This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.

Timeline

Start

2020-11-24

Primary completion

2022-12-16

Completion

2023-05-12

Outcome

Met primary endpoint

release “All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing.” celldex.com ↗

release “In patients with chronic inducible urticaria refractory to antihistamines, a single dose of CDX-0159 (3 mg/kg) resulted in rapid, profound, and durable responses in 100% of patients” celldex.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	barzolvolimab	Monoclonal antibody	—	Intravenous

Indications