Molecular Endotypes of Chronic Idiopathic Urticaria

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04774315

Enrollment

Registered

2021-03-01

Start date

2022-01-01

Completion date

2025-03-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Urticaria, Idiopathic

Brief summary

This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.

Interventions

DRUGOmalizumab

omalizumab 300mg SQ every 4 weeks as part of standard of care

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* CIU as defined as frequent urticarial lesions for ≥ 6 weeks * Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily) * Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria

Exclusion criteria

* Use of immunomodulatory drugs in the past 1 month prior to beginning the study * Use of systemic steroids in the past 1 month prior to beginning the study * Use of omalizumab in the past 3 months prior to beginning the study * Use of any investigational agent in the past 30 days * Untreated intercurrent illness * Severe Asthma * Primary diagnosis of flushing

Design outcomes

Primary

Measure	Time frame	Description
Responders	Week 16	The number of participants who meet the definition of Responder to omalizumab. Responders are defined as having a UAS7 of 6 or less after 16 weeks of treatment.

Secondary

Measure	Time frame	Description
Baseline expression of innate immune markers	Baseline	Baseline expression of innate immune markers in peripheral blood between eventual responders and nonresponders to omalizumab. 5 significant markers will be reported. Results will be stratified between groups determined by the pre-specified arms and by the classification of participants as responders versus non-responders to omalizumab.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026