An observational study in Chronic Urticaria, sponsored by Olivier Michel. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Olivier Michel · Observational
Among 10 studies in Chronic Urticaria with a site in Belgium — 2 open to participants now, 3 under way, 2 of them phase 3. Chronic Urticaria · Belgium.
Among the 10 studies in Chronic Urticaria with a site in Belgium, this one is one of 3 that started in 2018, is one of 2 observational ones, and was the 3rd registered.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
Browse Chronic Urticaria studies →2 of the 10 studies in Chronic Urticaria with a site in Belgium are open now. Recruiting first, the newest first:
KU Leuven · Sites in Belgium
Ages 18+ · Healthy volunteers
Celldex Therapeutics · Sites in Belgium, United States, Argentina and 27 more countries
Ages 18+
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 24 Chronic Urticaria studies recruiting now, 11 (46%) set no upper age limit and 9 (38%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 165 across 40 observational studies indexed under Chronic Urticaria.
Median enrollment 925 across the 8 interventional studies, 135 across the 2 observational. Of the 6 that completed or were terminated, 6 (100%) have results posted.
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8 of 10 have an industry lead sponsor. The 5 most frequent:
Olivier Michel is the lead sponsor of 2 studies on the registry; none are open to participants now.
Olivier Michel has 1 study filed under Chronic Urticaria — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Chronic Urticaria with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Chronic urticaria (CU) is a disease that usually affects a large visible amount of surface of the skin. It is accompanied by severe itch and feeling of burned skin. Therefore the disease has a big impact on the quality of life of patients. Unfortunately, to date CU is not easily controlled by its few existing treatment options (i.e. antihistamines, omalizumab, cyclosporine).
This research's main perspective is to improve quality of life for CU patients by first of all focusing on a good clinical diagnosis of (different subtypes of) CU in a CU reference center, and secondly by gaining more insight on the pathogenesis of the disease to expand knowledge on potential new targeted treatments for the patients.
Chronic urticaria (CU) is an inflammatory skin disease that is defined by the presence of urticaria (hives), on most days of the week, for a period of six weeks or longer. About 40 percent of patients with CU have accompanying episodes of angioedema. It is classified as chronic inducible urticaria (CIU) in which urticaria is induced by one or more environmental stimuli (such as heat, cold, pressure applied to the skin, exercise, water, vibration, and sunlight) and chronic spontaneous urticaria (CSU) which refers to CU in which appearance of lesions is not triggered by consistent or identifiable factors. At any given time, CU affects up to 1 percent of the general population in the United States, and the prevalence is believed to be similar in other countries. So far, epidemiological studies for a Belgian population haven't been performed yet.
It is generally proposed that patients with CU have defects in mast cell and/or basophil trafficking, signaling and/or function. Nevertheless more recently also other cells seem to be involved: lymphocytes, eosinophils, endothelial cells (ECs). The integrity of EC structure and function is important in the maintenance of the vessel wall and circulatory function. As a barrier, the endothelium is semi-permeable and controls molecular transport between the blood and the tissues. Under basal conditions, ECs are involved in maintaining the anti-thrombotic blood-tissue interface by regulating thrombosis, thrombolysis, platelet adherence, vascular tone and blood flow. In CU, mast cells are activated and histamine release occurs. This histamine binds to its receptor on the ECs causing vasodilation and extravasation. This endothelial function/dysfunction can be characterized by several biological markers from different signalization/activation pathways. Vascular injury induces release of vascular endothelial growth factor (VEGF) to stimulate angiogenesis. Cytokine stimulation triggers the expression and release of adhesion molecules (e.g., E-selectin, ICAM-1, VCAM-1), making transendothelial migration of lymphocytes possible. In particular, E-selectin is expressed only by activated endothelium; however, its circulating form (sE-selectin) can be found in the plasma after enzymatic cleavage or from shedding by damaged or active ECs. Furthermore it is known for ECs to interact with mast cells through the production of Stem Cell Factor (SCF; c-kit ligand) to influence mast cell proliferation and differentiation. Asero et al (2003) determined serum SCF levels in 65 CIU patients and found no difference from those found in healthy controls. Nevertheless, the increase in mast cells in skin biopsy specimens, along with the absence of systemic eosinophilia in CIU patients suggests a possible role for stem cell factor (SCF) in CU pathogenesis.
Endothelial progenitor cells (EPC) normally have the ability to develop into fully mature EC and contribute to neovascularization by targeting sites of endothelial injury. Furthermore it is shown that acute exercise-induced nitric oxide production contributes to upregulation of circulating endothelial progenitor cells in healthy subjects. Since exercise is a known trigger for CU, it would be interesting to investigate the effect of exercise on EPC recruitment and EC activation in CSU.
Microvascular damage and EC injury is described in multiple diseases such as diabetes and scleroderma. This can be evaluated by nail fold videocapillaroscopy (NVC). The integrity of vessel walls is compromised in CU, of which the appearance of wheals due to the extravasation process seems to be the most obvious symptom clinically. It would be interesting to examine if there are microscopical abnormalities on NVC that could help identify (certain subtypes of) CU. If present, correlations between these abnormalities and disease severity can be further investigated.
The objectives of the study are:
All patients with a diagnose of chronic urticaria receiving medical care within the CHU Brugmann Hospital. Diagnose performed according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.
The control group consists in patients beeing followed within the CHU Brugmann Hospital for the ellipsoid excision of atypical naevi on remnant healthy skin.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients diagnosed with chronic urticaria receiving medical care within the CHU Brugmann Hospital. Diagnose performed according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.
Exclusion Criteria:
None
50 consecutive chronic urticaria patients receiving medical care within the CHU Brugmann Hospital. Diagnose according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.
Procedure: Punch Biopsy · Procedure: Blood sampling
20 healthy control patients, without chronic urticaria. Patients coming to the CHU Brugmann hospital for the excision of atypical naevi.
Procedure: Punch Biopsy · Procedure: Blood sampling
A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.
Blood sampling
Stem cell factor expression
Immunohistochemistry performed on cryostat sections with a monoclonal antibody
Time frame: 6 months
E-selectin expression
Immunohistochemistry performed on paraformaldehyde fixed sections with a monoclonal antibody
Time frame: 6 months
Vascular endothelial growth factor (VEGF) expression
Immunohistochemistry performed with a monoclonal antibody on paraffin sections
Time frame: 6 months
C5B9 complement complex expression
Immunofluorescence staining performed on paraffin-embedded tissue blocks
Time frame: 6 months
Incidence of chronic inducible urticaria
Incidence of chronic inducible urticaria within the CHU Brugmann Hospital. Diagnose established by means of provocation tests.
Time frame: 6 months
Incidence of chronic spontaneous urticaria
Incidence of chronic spontaneous urticaria within the CHU Brugmann Hospital. Diagnose established by means of provocation tests.
Time frame: 6 months
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Dec 2022, 58 months after the start.
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Olivier Michel