A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Conditions

• Chronic Inducible Urticaria
• Cold Urticaria
• Cold-Induced Urticaria
• Symptomatic Dermographism

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Barzolvolimab — DRUG
  Subcutaneous Administration
• Matching Placebo — DRUG
  Subcutaneous Administration

Study Details

The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.

Key Dates

Start date

Jan 15, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: barzolvolimab in patients with Cold Induced Urticaria
  barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
• Placebo Comparator: Placebo in patients with Cold Induced Urticaria
  Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
• Experimental: barzolvolimab in patients with Symptomatic Dermographism
  barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
• Placebo Comparator: Placebo in patients with Symptomatic Dermographism
  Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.

Primary Outcome Measure

Complete response to provocation testing at Week 12 [ Time Frame: From Day 1 (first dose) to Week 12 ]

Central Contacts

• Celldex Therapeutics
  844-723-9363
  [email protected]

Locations (26)

Find similar trials in Birmingham, AL

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