Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03111628
Phase
PHASE4
Status
Completed

Conditions

  • Urticaria Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    omalizumab 300 mg every 4 weeks by subcutaneous injection

Study Details

This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE bearing cell type associated with clinical symptom change.

Key Dates

Start date
Oct 6, 2017
Status verified
May 2021
Primary completion
May 1, 2020
Completion
May 1, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Omalizumab
    Omalizumab 300mg every month for 3 doses

Primary Outcome Measure

Time to 50% Decline in Clinical Symptoms Measured by the Urticaria Activity Score Seven Day(UAS7) [ Time Frame: From first injection to time of meaningful change, up to 12 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Asthma and Allergy Center· Baltimore, MD

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