Clinical trial NCT03494881: Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
Official title: Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2018-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mepolizumab for the treatment of chronic spontaneous urticaria
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean UAS score 7
timeFrame: Study participants will document their CSU symptoms using a diary during the 10 week study period
Secondary outcomes:
measure: Mean reduction in ISS and UCT
timeFrame: 10 weeks of treatment with mepolizumab
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Study Principal Investigator
name: Jason C Sluzevich, M.D.
role: PRINCIPAL_INVESTIGATOR
References: