Early Phase 1
N=10
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT03494881 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Reduction in Urticaria Activity Score (UAS7) — 3; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Nucala (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Urticaria Activity Score (UAS7) |
3; 7 | — |
| SECONDARY Change in Short Form Urticaria Control Test Score (S-UCT) |
12.3; 0.71 | — |
| SECONDARY Change in Long Form Urticaria Control Test (L-UCT) Score |
21.3; 1.6 | — |
| SECONDARY Change in Itch Severity Score (ISS) |
13; 1 | — |
Summary
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
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
- If you are female and pregnant
- Biopsy proven neutrophilic rich urticaria
- Known history of adverse reaction to mepolizumab (Nucala)
Data sourced from ClinicalTrials.gov (NCT03494881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.