臨床研究等提出・公開システム

Date of registration	July. 07, 2024
Last modified on	July. 10, 2026
Trial ID	jRCT2031240209

Scientific Title	A Phase 1b Open label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects with Stargardt Disease and a Phase 2/3 Randomized, Double masked, and Placebo controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects with Stargardt Disease
Public Title	DRAGON II

Contact for Scientific Queries	Name	Mata Nathan
	Affiliation	Belite Bio, Inc
	Address	PO Box 309, Ugland House Grand Cayman, Cayman Islands KY1 1104
	Telephone	886-972-080-097
	E-mail	clinicaltrial@belitebio.com
Contact for Public Queries	Name	contact trial Clinical
	Affiliation	ICON Clinical Research GK
	Address	Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan
	Telephone	+81-6-4560-2001
	E-mail	Japan-Chiken@iconplc.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 24, 2024
Target sample size		66
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	Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene Subjects must have a defined aggregate atrophic lesion in 1 or both eyes Minimum BCVA is required in the study eye
	Exclusion Criteria	Any ocular disease other than STGD1 that, in the opinion of the investigator, would complicate assessment of a treatment effect History of ocular surgery in the study eye in the last 3 months Any prior gene therapy
	Age Minimum	12age old over
	Age Maximum	20age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stargardt Disease
Intervention(s)		Investigational medical product: 5 mg tinlarebant tablets. Administration route: oral. The proposed dose level for both the Phase 1b and Phase 2/3 parts of the study is 5 mg tinlarebant once daily. Reference product: placebo tablets Administration route: oral. Placebo will be administered in the Phase 2/3 part of the study only.
Primary Outcome(s)		To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy
Secondary Outcome(s)		To measure the annualized rate of change in total area of atrophy Change in BCVA measured by the ETDRS method

Primary Sponsor	Belite Bio, Inc

Name of Certified Review Board	National Hospital Organization Tokyo Medical Center Institutional Review Board
Address	2-5-1, Higashigaoka, Meguro-ku, Tokyo
Telephone	+81-3-3411-0111
Approval Status	Approval
Date of approval	June. 28, 2024

Plan to share IPD	No

Secondary ID(s)	NCT06388083

Countries of Recruitment（Except Japan）	United Kingdom/United States

History of Changes

No	Publication date
4	July. 10, 2026	(this page)	Changes
3	May. 15, 2026	Detail	Changes
2	Nov. 28, 2024	Detail	Changes
1	July. 07, 2024	Detail

List of change history