What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria, such as monoclonal antibodies like omalizumab, often have side effects that include injection site reactions, headaches, and an increased risk of infections. Other potential side effects can include dizziness, fatigue, and gastrointestinal issues. As with many biologic treatments, there is also a risk of hypersensitivity reactions, which can range from mild to severe. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of treatment.

What prior FDA approvals exist?

Omalizumab (Xolair) is a monoclonal antibody that has been FDA-approved for the treatment of Chronic Spontaneous Urticaria (CSU) in patients who remain symptomatic despite antihistamine treatment. Omalizumab works by binding to immunoglobulin E (IgE), thereby inhibiting the activation and degranulation of mast cells and basophils. This mechanism is somewhat similar to Barzolvolimab (CDX-0159), which targets the KIT receptor to inhibit mast cell activation and degranulation. Other treatments for CSU include antihistamines and corticosteroids, but these do not involve monoclonal antibodies or similar targeted mechanisms.

What other types of research exist?

Promising, novel alternatives to Barzolvolimab (CDX-0159) for Chronic Urticaria patients include Omalizumab, a monoclonal antibody targeting IgE, which has shown efficacy in treating Chronic Urticaria by reducing mast cell activation. Another potential alternative is Ligelizumab, an anti-IgE antibody that has demonstrated higher efficacy compared to Omalizumab in clinical trials. Both of these treatments offer new avenues for managing Chronic Urticaria by targeting the underlying immunological mechanisms.

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Monoclonal Antibodies

Barzolvolimab for Chronic Hives

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

Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine

Normal blood counts and liver function tests

Must not have

Clearly defined cause for chronic urticaria

Women who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to day 85 (week 12)

Summary

This trial is testing a new medication called barzolvolimab to help people with Chronic Spontaneous Urticaria, a condition that causes persistent hives and itching. The medication works by calming the immune system to reduce these symptoms.

Who is the study for?

This trial is for adults over 18 with chronic spontaneous urticaria (hives) lasting at least 6 months, who have been on a stable antihistamine regimen for over 4 weeks. Participants must not be pregnant or nursing, free from certain infections like HIV and hepatitis, and without other skin conditions or causes for their hives. They should also agree to use effective contraception and avoid live vaccines.

What is being tested?

The study is testing barzolvolimab's effects on chronic spontaneous urticaria compared to a placebo. It aims to understand how well the drug works, its safety profile, how it affects the body (pharmacodynamics), and how the body processes it (pharmacokinetics).

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, headaches, fatigue, nausea. The trial will closely monitor patients' health for any adverse reactions related to barzolvolimab.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic hives despite taking regular allergy medication.

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My blood and liver tests are normal.

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I have been on a stable dose of a non-drowsy allergy medication for at least 4 weeks.

Exclusion Criteria

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

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My chronic hives have a known cause.

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I am not pregnant or nursing.

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

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I have been treated with barzolvolimab before.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to day 85 (week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to day 85 (week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 85 (week 12) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

Secondary study objectives

Angioedema

Urticaria

Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

Trial Design

6Treatment groups

Experimental Treatment

Group I: barzolvolimab 75 mg then 300 mgExperimental Treatment1 Intervention

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks

Group II: barzolvolimab 75 mg then 150 mgExperimental Treatment1 Intervention

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks

Group III: barzolvolimab 300 mgExperimental Treatment1 Intervention

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks

Group IV: barzolvolimab 150 mgExperimental Treatment1 Intervention

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks

Group V: Placebo then barzolvolimab 300 mgExperimental Treatment2 Interventions

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks

Group VI: Placebo then barzolvolimab 150 mgExperimental Treatment2 Interventions

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

0 / 8Eligibility 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

The most common treatments for Chronic Urticaria include antihistamines, omalizumab, corticosteroids, and emerging therapies like Barzolvolimab (CDX-0159). Antihistamines work by blocking H1 receptors to reduce itching and swelling. Omalizumab, an anti-IgE monoclonal antibody, binds to IgE, preventing it from attaching to mast cells and basophils, thereby reducing allergic reactions. Corticosteroids suppress the immune response and inflammation. Barzolvolimab (CDX-0159) targets the KIT receptor on mast cells, inhibiting their activation and degranulation, which is crucial in reducing the release of histamine and other mediators involved in urticaria. These mechanisms are vital for Chronic Urticaria patients as they directly address the underlying pathophysiology, providing symptom relief and improving quality of life.