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OpenTrials
Active, Not Recruiting

NCT Number: NCT04774315

Molecular Endotypes of Chronic Idiopathic Urticaria

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Urticaria, Idiopathic Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

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

Primary outcomes

  1. Responders

    Time frame: 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 outcomes

  1. Baseline expression of innate immune markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2021
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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