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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

Join a study on Barzolvolimab for chronic spontaneous hives.

Recruiting
18 years and older
All
Phase 3

Chronic Spontaneous Urticaria (CSU) is a condition where hives appear on the skin for a long time without an obvious reason. This study is testing a new medicine called barzolvolimab for adults with CSU who still have symptoms even after using regular allergy medicines called H1-antihistamines. The study compares barzolvolimab to a placebo, which is a substance with no active medicine, to see if it helps people feel better.

The study lasts a total of 68 weeks, which includes 4 weeks of screening, 24 weeks of placebo-controlled treatment, 28 weeks of active barzolvolimab treatment, and 16 weeks without treatment. Participants need to be at least 18 years old, have had CSU for at least 6 months, and be on a stable allergy medicine regimen. They also must agree to use effective birth control during and after the study if they can have children.

  • The study involves several visits and requires participants to keep a daily electronic diary of their symptoms.
  • Participants will be randomly assigned to receive either barzolvolimab or a placebo initially.
  • Participants should not have certain other medical conditions or have been vaccinated with live vaccines recently.
Study details
    Chronic Spontaneous Urticaria

NCT06455202

Celldex Therapeutics

23 February 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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.
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