Mepolizumab for Hives

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of Mepolizumab, also known as Nucala, to treat chronic spontaneous urticaria, which are persistent hives appearing without a clear cause. The goal is to determine if Mepolizumab can benefit individuals who haven't responded to standard antihistamine medications. Participants will receive the active treatment, as the trial does not include a placebo group. Suitable candidates have chronic hives unresponsive to typical allergy medicine and are generally in good health. As an Early Phase 1 trial, this research aims to understand how Mepolizumab works in people, offering participants a chance to be among the first to receive this treatment.

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.

Is there any evidence suggesting that Mepolizumab is likely to be safe for humans?

Research has shown that mepolizumab is generally safe. Studies indicate that reactions such as hives, redness, and rash occur in less than 1% of cases, similar to those taking a placebo, meaning serious side effects are rare.

Mepolizumab has also been used safely for conditions like asthma over a long period, supporting its safety in humans. Although this study is in an early phase, these findings suggest that mepolizumab is usually well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hives?

Mepolizumab is unique for treating hives because it targets a specific part of the immune system known as interleukin-5 (IL-5). Unlike the standard treatments for hives, which typically include antihistamines and corticosteroids, mepolizumab works by reducing the number of eosinophils, a type of white blood cell involved in causing inflammation and allergic reactions. Researchers are excited about mepolizumab because it offers a targeted approach, potentially improving symptoms for patients who do not respond well to current therapies.

What evidence suggests that Mepolizumab might be an effective treatment for chronic spontaneous urticaria?

Research has shown that mepolizumab might help treat chronic spontaneous urticaria, also known as chronic hives. In one study on a similar condition, 56% of patients who received mepolizumab had their symptoms completely disappear by week 8, meaning more than half of the patients no longer experienced any symptoms. Another study found that mepolizumab greatly reduced the need for oral steroids, which are often used to manage symptoms. Although these findings are preliminary, they suggest that mepolizumab could effectively reduce hive symptoms and improve patients' quality of life.

In this trial, all participants will receive active treatment with mepolizumab, as there is no placebo arm. ^{2 3 6 7 8}

Who Is on the Research Team?

Jason C Sluzevich, M.D.

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7931148/

Efficacy and Safety of Biologic Agents in Chronic Urticaria ... The SIRUS trial additionally showed that mepolizumab helped decrease oral prednisone dose in patients dependent on oral steroids. Unfortunately, in our cohort, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03494881

NCT03494881 | Mepolizumab for the Treatment of Chronic ... The primary endpoint will be the mean reduction in the seven day urticaria activity score (UAS7) before and after 10 weeks of treatment with mepolizumab. ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)00852-3/fulltext

Chronic urticaria: unmet needs, emerging drugs, and new ... Recently, data from the cholinergic urticaria cohort have demonstrated complete response by week 8 in five (56%) of nine patients treated with ...

4. xolairhcp.com xolairhcp.com/chronic-spontaneous-urticaria/efficacy/clinical-trial-results.html

Chronic Spontaneous Urticaria (CSU) Treatment Clinical Trial ... *In Study 1, 36% of patients achieved zero itch and zero hives with XOLAIR 300 mg. In Study 2, 44% of patients achieved zero itch and zero hives with XOLAIR 300 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10967551/

Real-World Effectiveness of Mepolizumab in Patients with ... The proportion of patients with any OCS use significantly decreased from the baseline to follow-up period by 16.1% and 17.3% in the allergic and ...

6. nucalahcp.com nucalahcp.com/nasal-polyps/efficacy-safety/safety-profile/

Safety Profile | NUCALA (mepolizumab) for HCPs Systemic reactions, including hypersensitivity: <1% NUCALA, <1% placebo. Manifestations included urticaria, erythema, and rash. 1 of 3 reactions occurred on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10748586/

A real-world disproportionality analysis of mepolizumab based ... In addition, although mepolizumab has exhibited favorable long-term safety in clinical studies (Gleich et al., 2021; Maspero et al., 2022), long ...

8. nucalahcp.com nucalahcp.com/severe-eosinophilic-asthma/efficacy-safety/safety-profile/

SEA Safety Profile | NUCALA (mepolizumab) for HCPs Learn about NUCALA's safety profile from adverse reactions reported in studies for patients with severe eosinophilic asthma including 6.4-year safety data.