Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

NCT03494881 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 17-009322
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Nucala

Interventions

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.

Also known as: Mepolizumab

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vulnerable study population
• If you are female and pregnant
• Biopsy proven neutrophilic rich urticaria
• Known history of adverse reaction to mepolizumab (Nucala)

Sponsors & Collaborators

• Mayo Clinic: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jason Sluzevich, M.D.
• Organization: Mayo Clinic

sluzevich.jason@mayo.edu

904-953-6192

Study Officials

• Jason C Sluzevich, M.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mepolizumab for the treatment of chronic spontaneous urticaria

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: July 30, 2019
• Primary Completion: November 15, 2023
• Study Completion: February 25, 2025
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)