Trials Sponsors Conditions Drugs Pricing

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

NucalaDrug

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

GlaxoSmithKline
Industrycollaborator
Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

MeSH Terms

Conditions

Chronic Urticaria

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

Jason C Sluzevich, M.D.
Study Principal Investigator
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

10 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 11, 2018

Study Start

July 30, 2019

Actual (reported)

Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations