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Study on the Effectiveness and Safety of Barzolvolimab for Patients with Chronic Inducible Urticaria

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Chronic Inducible Urticaria, which is a type of skin condition that causes itchy welts or hives. The study is testing a treatment called Barzolvolimab, also known by its code name CDX-0159. This treatment is being compared to a placebo to see how effective it is in helping patients with this condition. The trial aims to find out if different doses of Barzolvolimab can help reduce the symptoms of Chronic Inducible Urticaria, specifically in subtypes like Cold Urticaria and Symptomatic Dermographism.

The study is designed to be a randomized, double-blind, placebo-controlled trial. This means that participants will be randomly assigned to receive either the treatment or a placebo, and neither the participants nor the researchers will know who is receiving which until the study is completed. The trial will last for several weeks, during which participants will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The main goal is to see if the treatment can help patients achieve a negative provocation test, which means they do not develop hives when exposed to certain triggers.

Throughout the study, participants will be monitored to assess the safety and effectiveness of Barzolvolimab. The trial will measure how well the treatment works by looking at changes in the symptoms of Chronic Inducible Urticaria over time. The study will also track any side effects that participants may experience. The results will help determine if Barzolvolimab is a safe and effective treatment option for people with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient provides written informed consent after understanding the study's nature.

    The patient must be willing and able to comply with all study requirements, including completing a daily diary during screening and throughout the study.

  2. Step 2

    Screening phase

    The patient undergoes a screening process to confirm eligibility, which includes a diagnosis of chronic inducible urticaria (ColdU or SD) for at least 3 months.

    The patient must have been on a stable regimen of a second-generation non-sedating H1 antihistamine for at least 4 weeks prior to randomization.

  3. Step 3

    Randomization

    The patient is randomly assigned to receive either the study medication, barzolvolimab, or a placebo.

    The medication is administered subcutaneously as a concentrate for solution for infusion.

  4. Step 4

    Treatment phase

    The patient receives the assigned treatment over a 20-week period.

    The primary goal is to assess the efficacy of different dose regimens of barzolvolimab in achieving a negative provocation test.

  5. Step 5

    Evaluation

    The primary endpoint is the proportion of patients with a negative provocation test at Week 12.

    Secondary endpoints include changes from baseline to Week 12 in various measures and the proportion of patients experiencing treatment-emergent adverse events.

  6. Step 6

    Completion

    The study is estimated to end by September 30, 2025.

    The patient completes the study after the final evaluation and data collection.

Who can join the trial?

10 criteria

  • Must have read, understood, and signed a written consent form after the study details have been explained.
  • Must be willing and able to follow all study requirements, including keeping a daily diary for at least 6 out of 7 days before starting the study.
  • Must be male or female and at least 18 years old.
  • Must have been diagnosed with ColdU or SD for at least 3 months before the first screening visit.
  • Must have chronic ColdU or SD that is not controlled even with a stable dose of a second-generation non-sedating H1AH (a type of allergy medication) for at least 4 weeks before starting the study.
  • Must have a positive reaction in provocation tests, which means developing a wheal (a raised, itchy area of skin) within 10 minutes after testing with specific tools at both the screening and randomization visits.
  • Blood tests must show normal levels of hemoglobin, white blood cells, neutrophils, and platelets, or slightly higher levels that are not considered significant by the study doctor.
  • Liver function tests must show aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels that are no more than twice the normal upper limit, and total bilirubin levels must be normal unless related to Gilbert’s Syndrome.
  • Females must use effective birth control methods or be of non-childbearing potential, such as being surgically sterile or in menopause.
  • Male participants must agree to use effective birth control methods with female partners who can have children and must not donate sperm for at least 150 days after receiving the study treatment. A vasectomy is considered an effective method if confirmed successful by a doctor.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Chronic Inducible Urticaria cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are part of a vulnerable population may not be eligible.
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Investigated drugs

CDX-0159 is an investigational medication being studied for its potential to help patients with chronic inducible urticaria, a condition where hives are triggered by specific stimuli. The trial aims to determine how effective and safe CDX-0159 is in reducing or eliminating the symptoms of this condition.

What is already known about the treatment

CDX-0159 – This medication is administered through an injection and is currently being studied in clinical trials for its effectiveness in treating chronic inducible urticaria, a condition characterized by hives triggered by specific stimuli. The drug is in the experimental phase, with ongoing research to determine its safety and efficacy. CDX-0159 works by targeting specific pathways in the immune system to reduce the symptoms of urticaria. It is classified as a monoclonal antibody, which is a type of medication designed to interact with specific proteins in the body to modulate immune responses.

Investigated diseases

Chronic Inducible Urticaria – This is a condition characterized by the recurrent appearance of hives or wheals on the skin, triggered by specific physical stimuli. The condition is chronic, meaning it persists for a long time, and inducible, as it is provoked by external factors such as cold or pressure. In the Cold Urticaria subtype, exposure to cold temperatures leads to the development of itchy welts on the skin. In the Symptomatic Dermographism subtype, physical pressure or friction on the skin results in similar reactions. The hives typically appear within minutes of exposure to the trigger and can last for several hours. The condition can significantly impact daily activities and quality of life due to its persistent and unpredictable nature.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516988-87-00Protocol codeCDX0159-07Estimated enrolment197 patientsSponsorCelldex Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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