臨床研究等提出・公開システム

Japanese

Date of registration	May. 22, 2025
Last modified on	May. 22, 2025
Trial ID	jRCT1050250027

Scientific Title	Identification of self-reactive IgE and self-antigens in chronic idiopathic urticaria
Public Title	Research on the pathogenesis of idiopathic urticaria

Contact for Scientific Queries	Name	Fujimoto Manabu
	Affiliation	The University of Osaka Hospital
	Address	2-2 Yamadaoka, Suita, Osaka
	Telephone	+81-668793031
	E-mail	yutakam0616@yahoo.co.jp
Contact for Public Queries	Name	Matsumura Yutaka
	Affiliation	The University of Osaka Hospital
	Address	2-2 Yamadaoka, Suita, Osaka
	Telephone	+81-668793031
	E-mail	ymatsumu@derma.med.osaka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 22, 2025
Actual date of first enrollment
Target sample size		60
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	1. Individuals who meet the diagnostic criteria for chronic idiopathic urticaria as outlined in the 2018 Urticaria Treatment Guidelines. Specifically, individuals who have experienced itchy red patches that appear and disappear within 24 hours for a period of six weeks or longer. 2. Individuals who are 18 years of age or older at the time of consent. 3. Individuals who have provided written consent to participate in the study.
	Exclusion Criteria	1. Pregnant or breastfeeding women 2. Individuals with atopic dermatitis 3. Individuals who have used omalizumab, an anti-IgE monoclonal antibody, within the past 3 months 4. Other individuals deemed ineligible by the principal investigator or sub-investigator
	Age Minimum	18age old exceed
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		chronic idiopathic urticaria
Intervention(s)
Health Condition(s) Keyword		chronic idiopathic urticaria
Intervention(s) Keyword
Health Condition(s) Code		D000080223
Intervention(s) Code
Primary Outcome(s)		No evaluation items for basic research. The correlation between the following clinical information and clinical sample analysis results will be examined. 1. Basic information: age, gender, how long you have had the disease, Urticaria Activity Score 2. What you have already had: atopic dermatitis, bronchial asthma, allergic rhinitis, angioedema, autoimmune diseases 3. Medications you are taking: antihistamines, antiallergic drugs, steroids, immunosuppressants, biologics 4, Blood values: white blood cell count, leukocyte formula, immunoglobulin, anti-TPO IgG antibodies, antinuclear antibodies
Secondary Outcome(s)

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Sanofi
Secondary Sponsor	Not applicable

Source of Monetary Support	Maruho
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka Suita, Osaka
Telephone	+81-6-6210-8270
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	May. 08, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none