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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03494881
Other study ID # 17-009322
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date July 30, 2019
Est. completion date May 2024

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Nucala
All study participants will receive Nucala (2) 100mg SQ injections administered at two different anatomical sites at week zero, 2,4,6, and 8 for a total of 5 doses.

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Active, not recruiting NCT05795153 - A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. Phase 3
Completed NCT03580369 - A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Phase 3
Completed NCT05030311 - A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines Phase 3
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Active, not recruiting NCT05107115 - Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine Phase 2
Recruiting NCT06042478 - A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. Phase 3
Terminated NCT04159701 - A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria Phase 2
Completed NCT03749135 - Dupilumab in Chronic Spontaneous Urticaria Phase 2
Completed NCT02649218 - A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients Phase 2
Active, not recruiting NCT05368285 - A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 2
Completed NCT05373355 - Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria. Phase 1
Not yet recruiting NCT06250400 - Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU) Phase 4

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