Deep Phenotyping of CIndU

NCT07359430 | Recruiting DMC

• 1 other identifier: CHDR2324
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Skin Diseases; Angio-Oedema and/or Urticaria

Keywords

Chronic inducible urticaria; Symptomatic dermographism

Outcome Measures

Primary Outcomes (16)

• Absolute eosiniphil count

  cells/µL

  Baseline - day 99

• IgG-anti-FcεRI

  IU/mL

  Baseline - day 99

• Absolute basophil count

  cells/µL

  Baseline - day 99

• C-reactive protein

  mg/L

  baseline - day 99

• D-dimer

  µg/mL

  Baseline - day 99

• Complement assessment

  mg/dL

  Baseline - day 99

• Total serum IgE

  IU/mL

  Baseline - day 99

• Basophil activcation test (BAT)

  % activation or Stimulation index

  Baseline - day 99

• Cytokine profile assessment

  pg/mL

  Baseline - day 99

• Tissue mass cytometry (CyTOF)

  Skin punch biopsies (4mm) will be taken from (non-)lesional skin and healthy for tissue mass cytometry (CyTOF).

  Baseline - day 99

• RNA-sequencing analysis

  Skin punch biopsies (4mm) will be taken from (non-)lesional skin and healthy for RNA-sequencing analysis

  Baseline - day 99

• Next-generation sequencing of skin swabs

  The microbiome is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.

  Baseline - day 99

• Composition and diversity of faecal microbiota

  Faecal samples will be collected to measure the composition and diversity of gut microbiota.

  Baseline - day 99

• 3D Multispectral imaging

  The redness and superficial morphology of (non-)lesional skin sites and healthy skin will be determined using a 3D multispectral imaging system.

  Baseline - day 99

• Laser Speckle Contrast Imaging (LSCI)

  The cutaneous microcirculation of (non-)lesional skin sites and healthy skin will be monitored over a 40 second timespan with a laser speckle contrast imager.

  Baseline - day 99

• 2D photography

  Standardized 2D clinical photographs will be taken of lesional and non-lesional skin, as well as healthy control skin, to build a longitudinal photo library for visual assessment of disease morphology and treatment response over time.

  Baseline - day 99

Secondary Outcomes (9)

• Urticaria Activity Score over 7 days (UAS7)

  Baseline - day 99

• Urticaria Control Test (UCT)

  Baseline - day 99

• Dermatology Life Quality Index (DLQI)

  Baseline - day 99

• Symptomatic Dermographism Activity Score (SDAS)

  Baseline - day 99

• Symptomatic Dermographism Quality of Life Questionnaire (SD-QoL)

  Baseline - day 99

Study Arms (2)

Omalizumab

In this treatment arm, a total of 30 patients-comprising 10 with chronic spontaneous urticaria (CSU), 10 with symptomatic dermographism (SD), and 10 with cold urticaria (ColdU)-will receive omalizumab at a dose of 300 mg every 4 weeks.

Healthy volunteers

As a control group, 10 healthy volunteers without a history of inflammatory skin disease or atopic conditions will be included.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients

You may qualify if:

• Healthy volunteers
• Male and female subjects between 18-69 years of age; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination and vital signs.
• No clinically significant skin disease in the research area
• No history of hypertrophic scarring or keloid.
• Willing to give written informed consent and willing and able to comply with the study protocol.
• Negative TempTest and FricTest at screening.
• Participant is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 12 hours before study visit 1.
• Eligible patients:
• Male and female subjects aged ≥18 years
• Diagnosis of SD, ColdU or CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for ≥3 months and symptomatic disease despite treatment with H1 antihistamines (up to fourfold the approved dose).
• Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period. Patients are according to the stepped care model eligible to start treatment with omalizumab
• Willing to give written informed consent and willing and able to comply with the study protocol.
• Positive provocation test:
• For ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening and Baseline. Alternatively, patients with a negative TempTest® may also be included if they have a positive ice cube test;
• For SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3mm at both screening and Baseline.

You may not qualify if:

• Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.
• History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
• Loss or donation of blood over 500 mL within three months prior to screening.
• Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIB ab) at screening
• Known infection requiring (topical or oral) antibiotic therapy within 56 days prior to Day 1.
• The use of systemic antibiotic therapy for \>2 months the past 12 months.
• The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives.
• Treatment with omalizumab within 5 half lives (120 days) prior to Day 1
• Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.
• Have any current and/or recurrent clinically significant or subject reported skin condition other than the CInDU/CSU wherefore subject is included in the study.
• Evidence of current drug or alcohol abuse.
• History of regular alcohol consumption within 12 months of the trial defined as an average weekly intake of \>21 alcoholic drinks/week for men or \>14 alcoholic drinks/week for women (i.e., 1 drink is equivalent to 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)
• Healthy volunteers
• \- Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year.
• Eligible patients

Sponsors & Collaborators

• UMC Utrecht: collaborator
• Centre for Human Drug Research, Netherlands: lead
• Erasmus Medical Center: collaborator

Study Sites (3)

Centre for Human Drug Research

Leiden, South Holland, 2333CL, Netherlands

COMPLETED

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples * Skin punch biopsies * Tape strips of skin surface * Swab of skin surface

MeSH Terms

Conditions

Skin Diseases; Chronic Inducible Urticaria; Familial dermographism

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: January 22, 2026
• Study Start: January 21, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

NL (3)