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Clinical trial

Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

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Last updated:1st Mar 2019
Identifier: NCT03494881

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

Detailed 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.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Mepolizumab for the treatment of chronic spontaneous urticaria
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
Estimated Study Start Date: March 1, 2019
Estimated Primary Completion Date: March 15, 2020
Estimated Study Completion Date: June 15, 2020

- Experimental:
Treatment Arm

Category Value
Date last updated at source 2019-02-26
Study type(s) Interventional
Expected enrolment 20
Study start date 2019-03-01
Estimated primary completion date 2020-03-15

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