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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucala | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Urticaria Activity Score (UAS7) | 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. | Baseline to 10 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Form Urticaria Control Test Score (S-UCT) | The short form urticaria control test (S-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The S-UCT consists of 4 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum S-UCT scores are 0-16 with 16 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline S-UCT score and non-responders if they had <95% reduction in baseline S-UCT score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason C Sluzevich, M.D. | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | This was an open-label pilot investigation and all study participants were assigned to active treatment. There was no placebo arm in this study. Nucala: All study participants received 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | This was an open-label pilot investigation and all study participants were assigned to active treatment. There was no placebo arm in this study. Nucala: All study participants received 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Urticaria Activity Score (UAS7) | 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. | Posted | Count of Participants | Participants | Baseline to 10 Weeks |
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Adverse events were collected from baseline through end of study participation, approximately 10 weeks.
This study defined an adverse event as an untoward or undesirable experience associated with the use of Mepolizumab (Nucala) in a research subject. Adverse events were collected through non-directed questioning of subjects at each follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | This was an open-label pilot investigation and all study participants were assigned to active treatment. There was no placebo arm in this study. Nucala: All study participants received 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Swelling | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Sluzevich, M.D. | Mayo Clinic | 904-953-6192 | sluzevich.jason@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Aug 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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Mepolizumab for the treatment of chronic spontaneous urticaria
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| Baseline to 10 weeks |
| Change in Long Form Urticaria Control Test (L-UCT) Score | The long form urticaria control test (L-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The L-UCT consists of 8 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum L-UCT scores are 0-32 with 32 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline L-UCT score and non-responders if they had <95% reduction in baseline L-UCT score. | Baseline to 10 Weeks |
| Change in Itch Severity Score (ISS) | The weekly itch severity score measures the intensity and impact of itching (pruritus). It is calculated using the pruritus score of the daily Urticaria Activity Score (UAS) score summed over a week. Scores range from 0 to 21 with higher scores indicating worse itching. Participants were considered responders if they had ≥ 95% reduction in baseline ISS score and non-responders if they had <95% reduction in baseline ISS score. | Baseline to 10 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Short Form Urticaria Control Test Score (S-UCT) | The short form urticaria control test (S-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The S-UCT consists of 4 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum S-UCT scores are 0-16 with 16 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline S-UCT score and non-responders if they had <95% reduction in baseline S-UCT score. | 10 total participants were analyzed. Those 10 participants were further broken down into the following categories non-responders (7) and responders (3), respectively. | Posted | Mean | Full Range | score on a scale | Baseline to 10 weeks |
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| Secondary | Change in Long Form Urticaria Control Test (L-UCT) Score | The long form urticaria control test (L-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The L-UCT consists of 8 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum L-UCT scores are 0-32 with 32 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline L-UCT score and non-responders if they had <95% reduction in baseline L-UCT score. | 10 total participants were analyzed. Those 10 participants were further broken down into the following categories non-responders (7) and responders (3), respectively. | Posted | Mean | Full Range | score on a scale | Baseline to 10 Weeks |
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| Secondary | Change in Itch Severity Score (ISS) | The weekly itch severity score measures the intensity and impact of itching (pruritus). It is calculated using the pruritus score of the daily Urticaria Activity Score (UAS) score summed over a week. Scores range from 0 to 21 with higher scores indicating worse itching. Participants were considered responders if they had ≥ 95% reduction in baseline ISS score and non-responders if they had <95% reduction in baseline ISS score. | 10 total participants were analyzed. Those 10 participants were further broken down into the following categories non-responders (7) and responders (3), respectively. | Posted | Mean | Full Range | score on a scale | Baseline to 10 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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