Celldex Therapeutics, Inc.’s barzolvolimab performed well in Phase 2 clinical trial of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD), the Company reports.
Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.
Celldex recently announced the start of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2).
The Phase 2 study is a randomized, double-blind, placebo-controlled, parallel group study evaluating the efficacy and safety profile of two dose regimens of barzolvolimab in patients with CIndU who remain symptomatic despite antihistamine therapy. 196 patients in two cohorts (differentiated by CIndU subtype) including 97 patients with ColdU and 99 patients with SD were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase.
Patients then enter a follow-up phase for an additional 24 weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at Week 12 (using TempTest for ColdU and FricTest for SD). Secondary endpoints include safety and other assessments of clinical activity including CTT (critical temperature threshold), CFT (critical friction threshold) and WI-NRS (worst itch numeric rating scale).
Barzolvolimab achieved the primary efficacy endpoint, a statistically significant difference between the percent of patients with a negative provocation test compared to placebo at Week 12 as assessed by the TempTest in ColdU and the FricTest in SD. In addition, barzolvolimab demonstrated rapid, durable, and clinically meaningful responses in patients with CIndU refractory to antihistamines. Demographics and baseline disease characteristics were well balanced across treatment groups.
Barzolvolimab was well tolerated with a favorable safety profile consistent with prior studies. Most adverse events were mild to moderate in severity; through 12 weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were hair color changes (13%) and neutropenia (11%). The rate of infections was similar between barzolvolimab-treated patients and placebo with no association between neutropenia and infections.
PHOTO CREDIT: DermNet
