臨床研究等提出・公開システム

Date of registration	Oct. 15, 2024
Last modified on	Jan. 19, 2026
Trial ID	jRCT2031240403

Scientific Title	TK-042 Phase III Clinical Study A Double-blind, Parallel-group Phase III Study in Pediatric patients with Chronic Urticaria
Public Title	TK-042 Phase III Clinical Study A Double-blind, Parallel-group Phase III Study in Pediatric patients with Chronic Urticaria

Contact for Scientific Queries	Name	Nishiyama Kenichi
	Affiliation	Teikoku Seiyaku Co., Ltd.
	Address	6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo
	Telephone	+81-3-6264-9123
	E-mail	clinical_trial@teiyaku.co.jp
Contact for Public Queries	Name	Clinical Development Department
	Affiliation	Teikoku Seiyaku Co., Ltd.
	Address	6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo
	Telephone	+81-3-6264-9123
	E-mail	clinical_trial@teiyaku.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 02, 2024
Actual date of first enrollment		Dec. 09, 2024
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- >= 7 to < 12 years of age. - Chronic urticaria for over 6 weeks
	Exclusion Criteria	- With the primary diagnosis of stimulus-inducible urticaria (e.g. physical urticaria [cold , solar or heat, etc.], cholinergic urticaria, and contact urticaria). - Have concominant skin disorders which Principal/sub-investigator judges to afffect the efficacy evaluation. - With uncontrolled mild to moderate bronchial asthma (those who require injectable, oral, or inhaled steroid medications), or with severe bronchial asthma. - Have history of hypersensitivity to antihistamine drugs or any ingredients of investigational drugs. - Currently undergoing allergen immunotherapy such as sublingual immunotherapy or have undergone such therapy within the past 3 years prior to screening. - Have severe hepatobiliary disorders. - Have severe renal or urinary disorders.
	Age Minimum	7age old over
	Age Maximum	12age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic urticaria
Intervention(s)		Placebo or TK-042 administered orally as 1 tablet once daily for 1 week
Primary Outcome(s)		Change from baseline in UAS7(Urticaria Actively Score 7)

Primary Sponsor	Teikoku Seiyaku Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Sugiura Clinic Institutional Review Board
Address	4-4-16-301, Honcho, Kawaguchi-shi, Saitama, Saitama, Saitama
Telephone	+81-48-222-5015
E-Mail	sugiura-irb@eps.co.jp
Approval Status	Approval
Date of approval	Nov. 07, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Jan. 19, 2026	(this page)	Changes
3	Feb. 21, 2025	Detail	Changes
2	Dec. 02, 2024	Detail	Changes
1	Oct. 15, 2024	Detail

List of change history