Molecular Endotypes of Chronic Idiopathic Urticaria

NCT04774315 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 18-0850
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Urticaria, Idiopathic

Outcome Measures

Primary Outcomes (1)

• Responders

  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.

  Week 16

Secondary Outcomes (1)

• Baseline expression of innate immune markers

  Baseline

Study Arms (1)

Omalizumab

EXPERIMENTAL

Drug: Omalizumab

Interventions

Omalizumab DRUG

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

Omalizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Jenny Stitt, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 1, 2021
• Study Start: January 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)