臨床研究等提出・公開システム

Japanese

Date of registration	June. 10, 2025
Last modified on	June. 10, 2025
Trial ID	jRCT2051250045

Scientific Title	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-Group, Comparison Study to Assess the Preventive Effect of ART-123 for Sensory Symptoms of Oxaliplatin-Induced Peripheral Neuropathy.
Public Title	A Phase 3 Study to Assess the Preventive Effect of ART-123 for Sensory Symptoms of Oxaliplatin-Induced Peripheral Neuropathy.

Contact for Scientific Queries	Name	Tawara Shunsuke
	Affiliation	Asahi Kasei Pharma Corporation
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Asahi Kasei Pharma Corporation
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 10, 2025
Actual date of first enrollment
Target sample size		450
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 18 years of age or older at the time of signing the ICF - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - The most recent laboratory findings (including for liver and kidney) within 14 days prior to the planned randomization remain within acceptable ranges - Able to sufficiently understand the clinical study and give informed consent
	Exclusion Criteria	- Symptomatic peripheral neuropathy or documented history of peripheral neuropathy in medical record - Patient using anti-coagulants or fibrinolytic drugs - Active hepatitis B, or known hepatitis B surface antigen positive - Prior treatment history with thrombomodulin alfa - Administration of another investigational medicinal product within 30 days prior to randomization - Patient is pregnant (urine human chorionic gonadotropin or serum human chorionic gonadotropin positive) or breastfeeding or intends to get pregnant during the treatment period. If the patient or the patient's female partner is a fertile woman, the patient who cannot agree to appropriate contraception - Patients otherwise deemed as inappropriate to participate in the study by the investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Oxaliplatin-Induced Peripheral Neuropathy
Intervention(s)		ART-123 will be administered via intravenous drip.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The change from baseline in the total FACT/GOG-NTX4 score
Secondary Outcome(s)		Proportion of subjects who developed Grade 2 or higher peripheral sensory neuropathy (Common Terminology Criteria for Adverse Events: CTCAE)

Primary Sponsor	Asahi Kasei Pharma Corporation

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Sano Hospital Institutional Review Board
Address	2-5-1, Shimizugaoka,Tarumi-ku,Kobe city, Hyogo
Telephone	+81-78-785-1000
E-Mail
Approval Status	Approval
Date of approval	April. 15, 2025

Plan to share IPD	Yes
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none