What is the mechanism of action of this treatment?

Mepolizumab, an IL-5 inhibitor, works by targeting and inhibiting interleukin-5 (IL-5), a cytokine essential for the growth, activation, and survival of eosinophils. Eosinophils contribute to the inflammatory process in Chronic Urticaria. By reducing eosinophil activity, Mepolizumab decreases inflammation and alleviates symptoms. This mechanism is crucial for Chronic Urticaria patients as it addresses the underlying inflammation, potentially leading to better symptom control and improved quality of life.

What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria, particularly those involving biologics like Mepolizumab (an IL-5 inhibitor), often include omalizumab (an anti-IgE antibody). Known side effects of these treatments can include injection site reactions, headache, nasopharyngitis, and upper respiratory tract infections. More serious but less common side effects may include anaphylaxis and other hypersensitivity reactions. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Urticaria, including antihistamines and omalizumab (Xolair), an anti-IgE antibody. While Mepolizumab (Nucala), an IL-5 inhibitor that reduces eosinophil activity, is being studied for Chronic Urticaria, it is primarily approved for severe eosinophilic asthma. Other similar treatments targeting eosinophils include benralizumab (Fasenra) and reslizumab (Cinqair), both of which are also approved for severe eosinophilic asthma but not specifically for Chronic Urticaria.

What other types of research exist?

Promising novel alternatives to Nucala (Mepolizumab) for Chronic Urticaria patients include Dupilumab and Omalizumab. Dupilumab has shown efficacy in treating conditions with similar inflammatory pathways, such as atopic dermatitis and asthma. Omalizumab, an anti-IgE antibody, has been effective in treating allergic asthma and chronic spontaneous urticaria, making it a viable alternative.

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Monoclonal Antibodies

Mepolizumab for Hives

Phase < 1

Waitlist Available

Led By Jason C Sluzevich, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Unresponsive to oral antihistamine therapy

Clinical and/or histopathological diagnosis of conventional CSU

Must not have

Current or previous Xolair use

Biopsy proven neutrophilic rich urticaria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks of treatment with mepolizumab

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Mepolizumab, a medication that reduces inflammation, in patients with chronic spontaneous urticaria who do not respond well to typical treatments. The drug works by decreasing the number of certain immune cells that cause hives and itching.

Who is the study for?

This trial is for adults over 18 with chronic spontaneous urticaria (hives) that doesn't get better with antihistamines. Participants must be in good health overall and able to follow the study's procedures. Pregnant or nursing women, those planning pregnancy soon, people allergic to Nucala, severe asthma patients on high-dose steroids, and anyone who has used Xolair can't join.

What is being tested?

The trial is testing the effectiveness of a medication called Nucala (Mepolizumab) for treating chronic spontaneous urticaria when standard treatments like antihistamines don't work. It's an early-stage study aimed at gathering initial data on how well this drug works for hives.

What are the potential side effects?

While not specified here, common side effects of Nucala may include headache, injection site reactions, back pain, fatigue and an allergic reaction to the drug itself.

Eligibility Criteria

Inclusion Criteria

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

Select...

My condition didn't improve with allergy pills.

Select...

I have been diagnosed with chronic spontaneous urticaria.

Exclusion Criteria

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

Select...

I have used Xolair before or am currently using it.

Select...

My skin condition has been confirmed by a biopsy to be neutrophilic rich urticaria.

Select...

I have severe asthma and need high doses of steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks of treatment with mepolizumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks of treatment with mepolizumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks of treatment with mepolizumab 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 UAS score 7

Secondary study objectives

Mean reduction in ISS and UCT

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study.

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

Mepolizumab, an IL-5 inhibitor, works by targeting and inhibiting interleukin-5 (IL-5), a cytokine essential for the growth, activation, and survival of eosinophils. Eosinophils contribute to the inflammatory process in Chronic Urticaria. By reducing eosinophil activity, Mepolizumab decreases inflammation and alleviates symptoms. This mechanism is crucial for Chronic Urticaria patients as it addresses the underlying inflammation, potentially leading to better symptom control and improved quality of life.