What side effects are associated with this type of intervention?

Omalizumab, an anti-IgE monoclonal antibody used in the treatment of Chronic Idiopathic Urticaria, is generally well-tolerated but can have side effects. Common adverse effects include injection site reactions such as erythema, pain, or bruising. Hypersensitivity reactions like rash, pruritus, and urticaria have also been reported. Serious allergic reactions are rare but can include severe urticaria and hypersensitivity vasculitis. Neurocognitive symptoms and muscle toxicity are uncommon, and no significant evidence of neurocognitive impairment has been found in large trials.

What prior FDA approvals exist?

Omalizumab (Xolair) is an FDA-approved treatment for Chronic Idiopathic Urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment. Omalizumab works by targeting and neutralizing IgE antibodies, which play a key role in allergic reactions. This treatment has shown efficacy in reducing symptoms and improving quality of life for patients with CIU. Other treatments for chronic urticaria may include antihistamines, corticosteroids, and other immunomodulatory agents, but Omalizumab remains a significant option due to its targeted mechanism of action.

What other types of research exist?

Promising novel alternatives to Omalizumab for Chronic Urticaria patients include biologic agents targeting different pathways involved in the disease. These include Ligelizumab (an anti-IgE monoclonal antibody with higher affinity than Omalizumab) and Dupilumab (an IL-4 receptor alpha antagonist). Both have shown efficacy in clinical trials and represent potential treatment options for patients in 2024.

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Monoclonal Antibodies

Omalizumab for Chronic Urticaria

Phase 4

Waitlist Available

Led By Jenny Stitt, M.D.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)

CIU as defined as frequent urticarial lesions for ≥ 6 weeks

Must not have

Use of omalizumab in the past 3 months prior to beginning the study

Severe Asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to understand why some people with Chronic Idiopathic Urticaria (CIU) respond to omalizumab (Xolair). Omalizumab is a medication that helps reduce allergic reactions by blocking a specific protein. The study will test patients' blood and skin before treatment to find predictors of response. Omalizumab (Xolair) was first approved for the treatment of this condition in 2014.

Who is the study for?

This trial is for people who have had frequent hives for at least 6 weeks and haven't seen improvement with standard allergy pills. They should be starting treatment with omalizumab (Xolair) as part of their usual care because other treatments didn't work.

What is being tested?

The study is looking into why some patients with Chronic Idiopathic Urticaria (CIU) get better when treated with omalizumab. It involves examining participants' blood and skin before they start taking the medication to find patterns predicting a good response.

What are the potential side effects?

Omalizumab can cause side effects like joint pain, dizziness, earache, hair loss, tiredness, or more serious ones such as allergic reactions including trouble breathing and swelling of the face.

Eligibility Criteria

Inclusion Criteria

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

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My allergy symptoms are not managed by standard antihistamines.

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I have had hives for 6 weeks or more.

Exclusion Criteria

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

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I have not used omalizumab in the last 3 months.

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I have severe asthma.

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My main symptom is frequent flushing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

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

Treatment Details

Study Objectives

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

Primary study objectives

Responders

Secondary study objectives

Baseline expression of innate immune markers

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OmalizumabExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

2006

Completed Phase 4

~2350

0 / 5Eligibility 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

Omalizumab, an anti-IgE monoclonal antibody, works by binding to free IgE antibodies in the blood, preventing them from attaching to mast cells and basophils. This action inhibits the release of histamine and other inflammatory mediators that cause the symptoms of Chronic Urticaria, such as itching and hives. This mechanism is crucial for patients with Chronic Urticaria because it directly targets the underlying allergic response, providing relief from persistent symptoms that are often resistant to conventional antihistamines and other treatments.