18 and older, any sex, with Urticaria Chronic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to 50% Decline in Clinical Symptoms Measured by the Urticaria Activity Score Seven Day(UAS7)Primary· From first injection to time of meaningful change, up to 12 Weeks
The time (in days) to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score (UAS) from baseline (Wk -7 to Day -1) to the date at which an Minimally Important Difference (5 point change in weekly UAS 7) or achievement of \> 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the baseline.
The UAS is a validated measure of CIU disease activity calculated from the average of twic
Group
Value
95% CI
Basopenics
23
± 3
Non-basopenic
12
± 3
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03111628.