Chronic Spontaneous Urticaria Clinical Trial
Official title:
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
Verified date | December 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | May 2024 |
Est. primary completion date | November 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean UAS score 7 | Study participants will document their CSU symptoms using a diary,daily scoring for a) the number of wheals [none (=0 points), <10 (=1 point), 10-50 (=2 points), or >50 per day (=3 points)], and b) the intensity of pruritus [none (=0 points), mild (=1 point), moderate (=2 points), severe (=3 points)]. The daily UAS score is summed over a week to calculate the UAS7 score (range: 0-42). | Study participants will document their CSU symptoms using a diary during the 10 week study period | |
Secondary | Mean reduction in ISS and UCT | The weekly itch severity score is calculated using the pruritus score of the daily UAS score summed over a week (range: 0-21). The urticaria control test (UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. Each UCT item has 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum UCT scores are 0-16 with 16 points indicating complete disease control. | 10 weeks of treatment with mepolizumab |
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