Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Reduction in Urticaria Activity Score (UAS7)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •If you are female and pregnant
- •Biopsy proven neutrophilic rich urticaria
- •Known history of adverse reaction to mepolizumab (Nucala)
Arms & Interventions
Treatment Arm
This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study.
Intervention: Nucala (Drug)
Outcomes
Primary Outcomes
Reduction in Urticaria Activity Score (UAS7)
Time Frame: Baseline to 10 Weeks
Study participants documented their chronic spontaneous urticaria (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). Participants were considered responders if they had ≥ 95% reduction in baseline UAS7 score and non-responders if they had \<95% reduction in baseline UAS7 score.
Secondary Outcomes
- Change in Short Form Urticaria Control Test Score (S-UCT)(Baseline to 10 weeks)
- Change in Long Form Urticaria Control Test (L-UCT) Score(Baseline to 10 Weeks)
- Change in Itch Severity Score (ISS)(Baseline to 10 weeks)
Investigators
Jason Sluzevich MD
Principal Investigator
Mayo Clinic