Actively Recruiting
Exploratory Multi-centre Study to Profile Chronic Inducible Urticaria and Discover Biomarkers Comparing Patients to Chronic Spontaneous Urticaria and Healthy Volunteers
Led by Centre for Human Drug Research, Netherlands · Updated on 2026-01-22
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre for Human Drug Research, Netherlands
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating chronic inducible urticaria (CIndU), a group of skin disorders characterized by recurring itchy or burning wheals and angioedema triggered by specific factors. This study focuses on two common subtypes: symptomatic dermographism (SD) and cold urticaria (ColdU). The aim is to better understand these subtypes by identifying new biomarkers to improve diagnosis and treatment monitoring, as current methods rely mainly on patient history and clinical appearance without many objective tools. The study has two parts: Part A involves detailed biological analysis to characterize disease features and mechanisms in SD and ColdU patients. Part B monitors changes in these biomarkers during treatment with omalizumab, administered every four weeks. The study includes 30 patients divided among chronic spontaneous urticaria (CSU), SD, and ColdU groups receiving omalizumab, and 10 healthy volunteers as controls. Participants will undergo various assessments including blood tests, skin imaging, molecular analyses, and microbiome evaluations from baseline up to day 99. Patient-reported outcomes and activity tracking will also be used to evaluate disease activity and quality of life. This comprehensive monitoring aims to provide objective measures of disease status and response to treatment over the study period.
CONDITIONS
Brief Title
Deep Phenotyping of CIndU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects between 18 and 69 years of age in generally stable good health
- No clinically significant skin disease in the research area for healthy volunteers
- No history of hypertrophic scarring or keloid for healthy volunteers
- Willing to provide written informed consent and comply with the study protocol
- Negative TempTest and FricTest results at screening for healthy volunteers
- Diagnosis of symptomatic dermographism, cold urticaria, or chronic spontaneous urticaria for at least 3 months with moderate to severe symptoms
- Symptomatic disease despite treatment with H1 antihistamines at stable doses for at least 2 weeks
- Positive provocation test results for ColdU or SD patients; negative tests for CSU patients
- Female participants of reproductive potential must agree to use contraception from screening until end of study
- Willing to refrain from extensive skin washing or sweating before study visits
You will not qualify if you...
- Significant uncontrolled or unstable disease in any organ system
- History of immunological abnormalities or immune suppression that may interfere with the study
- Blood donation or loss over 500 mL within 3 months prior to screening
- Positive hepatitis B, hepatitis C, or HIV antibody tests
- Infection requiring antibiotic therapy within 56 days prior to Day 1
- Use of systemic antibiotics for more than 2 months in the past year
- Use of immunomodulatory or immunosuppressive medications within 28 days prior to Day 1 if judged interfering
- Treatment with omalizumab within 120 days prior to Day 1
- Pregnant, breastfeeding, or intending to become pregnant
- Current significant skin conditions other than CIndU or CSU
- Evidence of drug or alcohol abuse
- Excessive alcohol consumption within 12 months defined as over 21 drinks/week for men or 14 drinks/week for women
- Participation in another investigational drug study within 3 months or more than 4 times a year for healthy volunteers
- Active CSU or other CIndU forms interfering with assessments for CIndU patients
- Use of corticosteroids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, plasmapheresis, doxepin, H2 antihistamines, or leukotriene receptor antagonists within specified timeframes
- History or current malignancy except treated non-melanoma skin cancer
- Hypersensitivity to omalizumab or its components
- History of anaphylactic shock
- Evidence of parasitic infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 99 days
Participants undergo in-depth characterization and biomarker profiling through cellular, molecular, biophysical, imaging, and microbiome analyses to understand disease characteristics and mechanisms.
Regular assessments throughout the study period
Duration - Up to 99 days
Participants with chronic inducible urticaria receive omalizumab treatment at a dose of 300 mg every 4 weeks while biomarkers and disease response are monitored.
Visits every 4 weeks during treatment
Trial Site Locations
Total: 3 locations
1
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333CL
Completed
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
3
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584CX
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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