Actively Recruiting
Deep Phenotyping of CIndU
Led by Centre for Human Drug Research, Netherlands · Updated on 2026-01-22
40
Participants Needed
3
Research Sites
70 weeks
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
Chronic inducible urticaria (CIndU) is a group of skin disorders defined by recurrent itchy or burning wheals or angioedema that recur for more than six weeks with a specific triggering factor. This is different from chronic spontaneous urticaria which does not have a specific triggering factor. CIndU is subclassified in nine subtypes with each having its own specific trigger. These subtypes are further divided in physical urticarias (symptomatic dermographism, cold urticaria, delayed pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema) or non-physical urticarias, i.e., cholinergic urticaria, aquagenic urticaria, and contact urticaria. Symptomatic dermographism (SD) is the most prevalent subtype of the physical urticarias. Its prevalence in Western populations is estimated to be between 1-5%. Following SD, cold urticaria (ColdU) is the next most common form, its annual incidence is estimated to be 0.05%. In this study, patients with the ColdU and symptomatic SD subtypes will be enrolled. As of yet, disease diagnosis of SD and ColdU is mostly purely clinical (clinical picture + patients' history), as there is a lack of objective biomarkers. Currently only two objective tools are available for the diagnosis of SD and ColdU, which are the FricTest and Temptest (both provocation tests). In addition, there is a lack of objective biomarkers for the prediction of treatment response and for the monitoring of treatment effects, as this is nowadays only monitored by patient reported outcomes.
CONDITIONS
Official Title
Deep Phenotyping of CIndU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects between 18-69 years of age in stable good health
- No significant skin disease in the research area
- No history of hypertrophic scarring or keloid
- Willing to provide written informed consent and comply with the protocol
- Negative TempTest and FricTest for healthy volunteers
- Diagnosis of symptomatic dermographism, cold urticaria, or chronic spontaneous urticaria for at least 3 months with moderate to severe symptoms despite antihistamine treatment
- Stable antihistamine dose for at least 2 weeks prior to study start and during treatment
- Positive provocation test for ColdU or SD patients, negative tests for CSU patients
- Willing to avoid extensive skin washing 12 hours before visits
- Female participants of reproductive potential must agree to use contraception from screening until end of study
You will not qualify if you...
- Significant uncontrolled or unstable disease in any organ system
- History of immune abnormalities affecting study objectives
- Blood loss or donation over 500 mL within 3 months prior to screening
- Positive hepatitis B, hepatitis C, or HIV antibody test
- Recent infection requiring antibiotics within 56 days prior to Day 1
- Use of systemic antibiotics over 2 months in past year
- Use of oral/systemic immunomodulatory or immunosuppressive medication within 28 days prior to Day 1
- Treatment with omalizumab within 120 days prior to Day 1
- Pregnancy, breastfeeding, or intending to become pregnant
- Current significant skin conditions other than CIndU or CSU
- Evidence of drug or alcohol abuse
- History of high alcohol consumption within 12 months before trial
- Participation in another investigational drug study within 3 months before screening or more than 4 times a year
- Active CSU or other CIndU forms interfering with study assessments for CIndU patients
- Presence of active CIndU disease interfering with assessments for CSU patients
- Other urticarial or angioedema conditions like urticarial vasculitis or hereditary angioedema
- Use of certain medications (corticosteroids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide) within 30 days prior to Day 1
- Recent IV immunoglobulin G or plasmapheresis within 30 days prior to screening
- Regular doxepin use within 6 weeks prior to Day 1
- Use of H2 antihistamines or leukotriene receptor antagonists within 7 days prior to Day 1
- Current or history of 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
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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