Mepolizumab for Hives

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Xolair, Corticosteroids

Disqualifiers: Pregnancy, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not used Xolair before. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Mepolizumab for treating hives?

Mepolizumab has shown effectiveness in reducing symptoms in conditions with high levels of eosinophils (a type of white blood cell), such as severe asthma and hypereosinophilic syndrome, which suggests it might help with hives if they are related to eosinophils. ^{1 2 3 4 5}

Is Mepolizumab safe for humans?

Mepolizumab has been used for conditions like severe asthma, and while it is generally considered safe, there is a risk of serious allergic reactions (anaphylactic reactions) in some people. Careful monitoring after administration is recommended to manage any potential allergic reactions. ^{6 7 8 9 10}

How does the drug mepolizumab differ from other treatments for hives?

Mepolizumab is unique because it is a monoclonal antibody that targets interleukin-5 (IL-5), a protein involved in the activation of eosinophils (a type of white blood cell), which are key in inflammation. While it is primarily used for severe eosinophilic asthma, its mechanism of reducing eosinophil activity may offer a novel approach for treating hives, especially if they are related to eosinophilic activity. ^{6 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Jason C Sluzevich, M.D.

Principal Investigator

Study Principal Investigator

Eligibility Criteria

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.

Inclusion Criteria

Good general health as confirmed by medical history

My condition didn't improve with allergy pills.

I am willing and able to follow the study's requirements.

Exclusion Criteria

Known history of adverse reaction to Nucala

Pregnant or nursing women

Women planning a pregnancy within the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive 200 mg SC of mepolizumab at weeks 0, 2, 4, 6, and 8, with assessments of UAS7, ISS, and UCT scores

10 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mepolizumab

Trial Overview 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.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Mepolizumab, a monoclonal antibody that neutralizes IL-5, has shown effectiveness in reducing eosinophil levels in patients with eosinophilic diseases, including asthma and hypereosinophilic syndrome.

While initial trials showed limited impact on asthma symptoms, more recent studies indicate that mepolizumab significantly reduces asthma exacerbations and improves quality of life in patients with severe eosinophilic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab and eosinophil-mediated disease. Walsh, GM.[2019]

Mepolizumab significantly reduced the rate of clinically significant asthma exacerbations in Korean patients with severe eosinophilic asthma, demonstrating its efficacy in this population.

The safety profile of mepolizumab in Korean patients was consistent with that observed in the overall population, indicating it is a safe treatment option for severe eosinophilic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Kim, MK., Park, HS., Park, CS., et al.[2021]

In a study of 351 patients with severe eosinophilic asthma, initiating treatment with mepolizumab led to a significant reduction in the use of high-dose inhaled corticosteroids (ICS) over a 12-month period, with 49% of patients reducing or discontinuing ICS.

Patients who discontinued ICS after starting mepolizumab experienced lower rates of chronic oral corticosteroid (OCS) use, fewer exacerbations, and reduced reliance on short-acting β2-agonists, indicating improved clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world study of inhaled corticosteroid use in patients with severe eosinophilic asthma treated with mepolizumab. Corren, J., Silver, J., Molfino, NA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Severe eosinophilic asthma and aspirin-exacerbated respiratory disease associated to eosinophilic gastroenteritis treated with mepolizumab: a case report. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Real-word experience with mepolizumab: Does it deliver what it has promised? [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Mepolizumab and eosinophil-mediated disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Mepolizumab effectiveness on small airway obstruction, corticosteroid sparing and maintenance therapy step-down in real life. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Mepolizumab: 240563, anti-IL-5 monoclonal antibody - GlaxoSmithKline, anti-interleukin-5 monoclonal antibody - GlaxoSmithKline, SB 240563. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness and the Characteristics of a "Super-Responder" to Mepolizumab in Severe Eosinophilic Asthma. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A risk of serious anaphylatic reactions to asthma biologics: a pharmacovigilance study based on a global real-world database. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS). [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A real-world study of inhaled corticosteroid use in patients with severe eosinophilic asthma treated with mepolizumab. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mepolizumab in Severe Eosinophilic Asthma: A 2-Year Follow-Up in Specialized Asthma Clinics in Greece: An Interim Analysis. [2021]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Mepolizumab: A Review in Eosinophilic Asthma. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab. [2022]