What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria, especially those targeting specific pathways or receptors like Barzolvolimab (CDX-0159), often include monoclonal antibodies and biologics. Known side effects typically include injection site reactions, headache, nasopharyngitis, and gastrointestinal symptoms such as nausea. More serious but less frequent side effects can involve increased risk of infections, hypersensitivity reactions, and potential cardiovascular events. Monitoring for these adverse effects is crucial during treatment.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Chronic Urticaria, particularly for cases where H1-antihistamines are ineffective. Omalizumab, an anti-IgE monoclonal antibody, is one such drug that has been approved for Chronic Spontaneous Urticaria (CSU). It works by binding to IgE, thereby inhibiting its interaction with receptors on mast cells and basophils, which are key players in the pathophysiology of urticaria. Other treatments include second-generation H1-antihistamines like cetirizine and loratadine, which are preferred for their minimal sedative effects. Barzolvolimab (CDX-0159) is being studied for its potential to target and inhibit specific pathways or receptors involved in Chronic Inducible Urticaria, offering a new avenue for patients who do not respond to existing therapies.

What other types of research exist?

Promising novel alternatives to Barzolvolimab (CDX-0159) for Chronic Urticaria patients include biologics such as omalizumab, which targets IgE, and ligelizumab, which is a next-generation anti-IgE antibody. Both have shown efficacy in patients with Chronic Urticaria who do not respond to H1-antihistamines. Additionally, dupilumab, an IL-4 receptor alpha antagonist, may also be considered as it modulates the immune response involved in chronic inflammatory conditions.

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Monoclonal Antibodies

Barzolvolimab for Chronic Urticaria

Phase 2

Waitlist Available

Research Sponsored by Celldex Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines

Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial

Must not have

Active, pruritic skin condition in addition to CIndU

Known active HIV, hepatitis B or hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 20

Summary

This trial is testing a new medication called barzolvolimab for people with chronic hives that don't improve with regular allergy medicine. The study aims to see if barzolvolimab can reduce or eliminate their symptoms by blocking the body's reaction that causes hives. Participants will receive different doses of the medication over several months, followed by an additional observation period.

Who is the study for?

This trial is for adults with Chronic Inducible Urticaria (hives) not relieved by antihistamines. Participants must have had symptoms for at least 6 weeks, use effective contraception, and be willing to maintain a symptom diary. Excluded are those with additional risky medical conditions, active infections like HIV or hepatitis B/C, other skin conditions, pregnant/nursing women, history of anaphylaxis or recent live vaccines.

What is being tested?

The study tests barzolvolimab's effectiveness on hives unresponsive to H1-antihistamines. It involves comparing barzolvolimab against a placebo in terms of clinical effects and safety. The drug's behavior in the body will also be studied.

What are the potential side effects?

Potential side effects may include reactions at the injection site, general discomforts such as headaches or fatigue, allergic responses potentially leading to more severe issues if one has allergies to components of barzolvolimab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had itchy hives for more than 6 weeks despite taking antihistamines.

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I have been on a stable dose of a specific allergy medication for at least 4 weeks and agree to continue it during the trial.

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I developed a skin reaction quickly after a specific allergy test at two different visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition that is itchy in addition to chronic inducible urticaria.

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I do not have active HIV, hepatitis B, or hepatitis C.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients with a negative provocation test at week 12

Secondary study objectives

Change in provocation threshold and itch for ColdU

Change in provocation threshold for SD

Change in worst itch reported after provocation for ColdU

+4 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: barzolvolimab 300 mg in patients with Symptomatic DermographismExperimental Treatment1 Intervention

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Group II: barzolvolimab 300 mg in patients with Chronic Inducible Cold UrticariaExperimental Treatment1 Intervention

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Group III: barzolvolimab 150 mg in patients with Symptomatic DermographismExperimental Treatment1 Intervention

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Group IV: barzolvolimab 150 mg in patients with Chronic Inducible Cold UrticariaExperimental Treatment1 Intervention

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Group V: Placebo Comparator in patients with Chronic Inducible Cold UrticariaPlacebo Group1 Intervention

Placebo injection subcutaneous every 4 weeks for 20 weeks

Group VI: Placebo Comparator in patients with Symptomatic DermographismPlacebo Group1 Intervention

Placebo injection subcutaneous every 4 weeks for 20 weeks

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Urticaria, such as barzolvolimab (CDX-0159) and omalizumab, work by targeting specific pathways or receptors involved in the disease's pathophysiology. Barzolvolimab likely inhibits a pathway or receptor that contributes to the symptoms of Chronic Inducible Urticaria, providing relief for patients unresponsive to H1-antihistamines. Omalizumab, on the other hand, is an anti-IgE antibody that reduces the levels of free IgE, thereby decreasing the activation of mast cells and basophils, which are key players in the inflammatory response seen in Chronic Urticaria. These mechanisms are crucial as they offer alternative therapeutic options for patients who do not achieve symptom control with standard antihistamine treatments, improving their quality of life.

Efficacy of omalizumab in chronic spontaneous urticaria refractory to conventional therapy: analysis of 110 patients in real-life practice.