Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

  • STATUS
    Recruiting
  • End date
    Dec 6, 2022
  • participants needed
    20
  • sponsor
    Mayo Clinic
Updated on 6 May 2022
antihistamines
urticaria
antihistamine therapy
nucala

Summary

This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.

Description

This is an open-label, single arm exploratory study of mepolizumab in the treatment of CSU. 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. Secondary endpoints will be the mean reduction of the urticaria control test (UCT) score and the weekly itch severity score (ISS) before and after treatment. Enrollment examination will include a standardized history and examination, baseline UCT score, CBC with differential, serum IgE level, chronic urticaria index, IgE Fc receptor antibody functional assay, and a 4 mm punch biopsy of lesional skin to confirm the urticarial tissue reaction includes eosinophils and is not neutrophilic predominant. Patients will discontinue all anti-histamines and start cetirizine 10 mg PO BID which may be continued throughout the study duration. Patients will be provided with a log book to track daily urticaria signs and symptoms in a standardized manner for UAS scoring. At week 0 (enrollment visit +7 days), baseline UAS7 and ISS score will be assessed and skin biopsy results reviewed. Patients with a confirmatory skin biopsy will receive 200 mg SC of mepolizumab at week 0,2,4,6,and 8. UAS-7 and weekly ISS score will be calculated at week 0, 4, 8, and 10. UCT scoring will be calculated at week 0 and at week 10. Repeat CBC with differential, serum IgE level, and measures of basophil serum activation (chronic urticaria index, IgE FC Receptor antibody functional assay) will be assessed at week 10. Attached to this document is a protocol summary.

Details
Condition Chronic Spontaneous Urticaria
Treatment Nucala
Clinical Study IdentifierNCT03494881
SponsorMayo Clinic
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female patients 18 years or older
Clinical and/or histopathological diagnosis of conventional CSU
Unresponsive to oral antihistamine therapy
Good general health as confirmed by medical history
Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Patients who read and sign an approved informed consent for this study

Exclusion Criteria

Vulnerable study population
Pregnant or nursing women
Women planning a pregnancy within the study period
Current or previous Xolair use
Biopsy proven neutrophilic rich urticaria
Known history of adverse reaction to Nucala
Severe asthma requiring high-dose inhaled or systemic corticosteroids
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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