臨床研究等提出・公開システム

Date of registration	May. 01, 2026
Last modified on	May. 01, 2026
Trial ID	jRCT2031260105

Scientific Title	An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy
Public Title	An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

Contact for Scientific Queries	Name	Masutani Hiroshi
	Affiliation	A2 Healthcare Corporation
	Address	Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
	Telephone	+81-3-3830-1173
	E-mail	tev-56286_trialinfomation@a2healthcare.com
Contact for Public Queries	Name	Masutani Hiroshi
	Affiliation	A2 Healthcare Corporation
	Address	Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
	Telephone	+81-3-3830-1173
	E-mail	tev-56286_trialinfomation@a2healthcare.com

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 14, 2026
Target sample size		23
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product NOTE - Additional criteria apply, please contact the investigator for more information
	Exclusion Criteria	Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial Is of a vulnerable population (eg, people kept in detention or jail) Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial Note - Additional criteria apply, please contact the investigator for more information
	Age Minimum	30age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Multiple System Atrophy
Intervention(s)		TEV-56286 orally once daily for 96 weeks.
Primary Outcome(s)		Number of participants experiencing an adverse event Number of participants who withdrew from the trial due to an adverse event

Primary Sponsor	Teva Branded Pharmaceutical Products R&D LLC (ICCC: A2 Healthcare Corporation)

Name of Certified Review Board	Niigata University Medical & Dental Hospital Institutional Review Board
Address	754, Ichibancho Asahimachidori, Chuo-ku, Niigata-shi, Niigata, 951-8520, Japan, Niigata
Telephone	+81-25-223-6161
Approval Status	Approval
Date of approval	Feb. 25, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07197866
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	US/Germany/Israel/Spain/France/Italy