Deep Phenotyping of CIndU
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre for Human Drug Research, Netherlands
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Healthy volunteers and patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Omalizumab
Group B: Healthy volunteers
Trial outcomes
Primary outcomes
1
Absolute eosiniphil count
cells/µL
Time frame
Baseline - day 992
IgG-anti-FcεRI
IU/mL
Time frame
Baseline - day 993
Absolute basophil count
cells/µL
Time frame
Baseline - day 994
C-reactive protein
mg/L
Time frame
baseline - day 99Secondary outcomes
1
Urticaria Activity Score over 7 days (UAS7)
The Urticaria Activity Score over 7 days (UAS7) is a validated patient-reported outcome measure used to assess the severity and frequency of urticaria symptoms-specifically wheals (hives) and pruritus (itch)-over the previous week. Scores range from 0 to 42, with higher scores reflecting more severe disease activity. The UAS7 is applied exclusively in patients with chronic spontaneous urticaria (CSU) to monitor disease burden and evaluate treatment response.
Time frame
Baseline - day 992
Urticaria Control Test (UCT)
The Urticaria Control Test (UCT) is a validated patient-reported outcome measure used to assess disease control in patients with chronic spontaneous urticaria (CSU). The total UCT score ranges from 0 to 16, with higher scores indicating better disease control. This questionnaire is used exclusively in patients with CSU to monitor treatment response and disease management over time.
Time frame
Baseline - day 993
Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a validated patient-reported outcome measure that assesses the impact of skin diseases on patients' quality of life over the previous week. The total DLQI score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life. A score of 0 reflects no impact, whereas 30 represents the most severe impact on quality of life. The DLQI will be assessed in all patients across the included skin disease cohorts.
Time frame
Baseline - day 994
Symptomatic Dermographism Activity Score (SDAS)
The Symptomatic Dermographism Activity Score (SDAS) is a patient-reported outcome measure specifically designed to assess disease activity in individuals with symptomatic dermographism. Patients rate the severity of their symptoms, such as itching and whealing, over the previous 24 hours on a scale from 0 to 4, with higher scores indicating more severe symptoms. The SDAS will be assessed daily in patients with symptomatic dermographism throughout the study to monitor disease activity and treatment response.
Time frame
Baseline - day 99Sponsors and contacts
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Centre for Human Drug Research, Netherlands
Lead sponsor
UMC Utrecht
Collaborator
Erasmus Medical Center
Collaborator
Source ClinicalTrials.gov