Three-month, Single-center Study to Identify Biomarkers/Response to Xolair Therapy in Chronic Idiopathic Urticaria

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Idiopathic Urticaria

In brief

This is a single center, non-comparative exploratory study, to investigate the effect of omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic idiopathic urticaria who had remained symptomatic despite the use of high dose H1-antihistamines.

Key facts

Study ID

NCT02814630

Run by

Asthma Inc Clinical Research Center

People needed

20

Starts

2016-09-01

Expected to finish

2018-11-02

Last updated by the study team

2019-01-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • at least 6 weeks of chronic idiopathic urticaria with itching despite current use of up to x4 H1-antihistamines (Kaplan, 2004)
• an urticaria activity score (UAS) during a 7-day period (UAS7) of 16 or more (on a scale ranging from 0 to 42, with higher scores indicating greater activity and a minimally important difference [MID] of 9.5 to 10.5) (Mathias et al., 2012)
• a weekly itch-severity score (ISS) of 8 or more (on a scale ranging from 0 to 21, with higher scores indicating more severe itching and an MID of ≥5) during the 7 days before first treatment with omalizumab.
• All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test.*

You may not qualify if…

• • a clearly defined underlying cause for chronic urticaria (e.g., physical urticaria)
• routine administration (i.e., daily or every other day for ≥5 consecutive days) of systemic glucocorticoids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or intravenous immune globulin within the previous 30 days
• the use of any H2-antihistamine or leukotriene-receptor antagonist within 7 days preceding the screening visit
• a history of cancer
• a known hypersensitivity to omalizumab
• treatment with omalizumab within the previous year, or
• pregnant or nursing females*

Where it is running

• ASTHMA Inc Clinical Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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