Image

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)

Studying Barzolvolimab for cold-induced hives and skin conditions.

Recruiting
18 years and older
All
Phase 3

This study aims to test a new medicine called **barzolvolimab** in adults with two skin conditions: cold induced urticaria (ColdU) and symptomatic dermographism (SD). ColdU is when your skin gets itchy when exposed to cold, and SD is when your skin itches when scratched. The study compares barzolvolimab with a placebo, which looks like medicine but has no active ingredients.

The study includes different phases:

  • A Screening Period up to 4 weeks to check if you can join.
  • A 24-week treatment period where you get barzolvolimab or placebo.
  • A 28-week barzolvolimab treatment period where everyone gets the medicine.
  • A 16-week follow-up period to see how you're doing after treatment.

Key Points:

  • Participants must be 18 or older with ColdU or SD not controlled by antihistamines.
  • You must agree to use effective birth control during and after the study.
  • Previous use of barzolvolimab disqualifies you from joining.
Study details
    Chronic Inducible Urticaria
    Cold Urticaria
    Cold-Induced Urticaria
    Symptomatic Dermographism

NCT07266402

Celldex Therapeutics

17 October 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race*
Are you a healthy volunteer
Ethnicity*
Are you a healthy volunteer
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.