臨床研究等提出・公開システム

Japanese

Date of registration	April. 15, 2022
Last modified on	Aug. 20, 2024
Trial ID	jRCT2031210693

Scientific Title	A Phase 2a, randomized, double-blind, study of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
Public Title	A phase 2a study of TAS5315 in patients with chronic spontaneous urticaria

Contact for Scientific Queries	Name	Ali Nasermoaddeli
	Affiliation	Taiho Pharmaceutical Co., Ltd.
	Address	1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
	Telephone	+81-3-3293-2455
	E-mail	th-tas5315_clinical@taiho.co.jp
Contact for Public Queries	Name	Makoto Nagaoka
	Affiliation	Taiho Pharmaceutical Co., Ltd.
	Address	1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
	Telephone	+81-3-3293-2455
	E-mail	th-tas5315_clinical@taiho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 01, 2022
Actual date of first enrollment		June. 28, 2022
Target sample size		120
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	- Aged 18 to 75 years - Diagnosis of chronic spontaneous urticaria (CSU) - Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU - UAS7 score >= 16 and HSS7 score >= 8 during 7 days prior to study entry
	Exclusion Criteria	- Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema - Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching - Bleeding diathesis - Uncontrolled hypertension disease states - Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening - Nonresponse to omalizumab or other humanized anti-human IgE monoclonal antibody therapies - Have been treated with other Bruton's Tyrosine Kinase inhibitors - Pregnant or lactating women
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic spontaneous urticaria
Intervention(s)		Oral administration of TAS5315 0.25 to 4 mg, QD
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Secondary Outcome(s)		Assessment of UAS7(percentage of the complete absence of hives and itch (UAS7=0) and disease control (UAS7<=6)), ISS7, HSS7, UCT, DLQI, UAS (by physician), and AAS7

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Jimbo Orthopedics Institutional Review Board
Address	5-38-41,Hon-cho, Koganei-City, Tokyo
Telephone	+81-42-304-1801
E-Mail
Approval Status	Approval
Date of approval	Mar. 18, 2022

Plan to share IPD	No
Plan description	Taiho provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

Plan to share IPD

Plan description

Taiho provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Aug. 20, 2024	(this page)	Changes
3	Aug. 05, 2023	Detail	Changes
2	Aug. 11, 2022	Detail	Changes
1	April. 15, 2022	Detail

List of change history