FAQ

Information on the medical institutions conducting the clinical trial is available on the Ministry of Health, Labour and Welfare’s "Japan Registry of Clinical Trials (jRCT)." Please refer to the link below.
URL： https://jrct.mhlw.go.jp/en-latest-detail/jRCT2033230587

The trial is intended for patients diagnosed with osteoarthritis of the knee who meet specific symptom and progression criteria. Eligibility will be determined based on a medical examination at the participating institution. Recruitment information will be available via the Ministry of Health, Labour and Welfare’s "Japan Registry of Clinical Trials (jRCT)," so please check the site and consult with the relevant medical institution.
URL： https://jrct.mhlw.go.jp/en-latest-detail/jRCT2033230587

Updates on the clinical trial are posted on the Japan Registry of Clinical Trials (jRCT) and are updated as information becomes available.
URL： https://jrct.mhlw.go.jp/en-latest-detail/jRCT2033230587

With respect to further details, due to the proper conduct of the trial at medical institutions, compliance with applicable regulatory requirements, and confidentiality obligations under agreements with our research partners, we do not disclose interim progress on a case-by-case basis.

To ensure scientific validity, clinical trial data can be disclosed only after the study has been completed, statistical analyses have been performed, and the results have been evaluated in aggregate. These steps are essential for accurately assessing the treatment effects on subjects and to ensure fair and appropriate handling of data.

The reasons why clinical trial data are generally disclosed after the final analysis are as follows:

1. Protecting scientific integrity: If interim results are leaked, bias may be introduced and the study may no longer be valid. Because clinical trials are conducted based on scientific verification, allowing for an appropriate evaluation of the treatment effects on subjects, the disclosure of interim results is strictly limited.
2. Protecting privacy: Before final analyses, anonymization may be insufficient, which can increase the risk of re-identification or inference of personal information.
3. Regulatory requirements: Relevant regulations and related frameworks define the process for public disclosure of final results.

   	Regulatory authorities	Law or framework	Summary
   Japan	Ministry of Health, Labour and Welfare (MHLW)	GCP Ministerial Ordinance	“Ministerial Ordinance on Good Clinical Practice for Trials of Drugs” (commonly referred to as the GCP Ministerial Ordinance)
   United States	Food and Drug Administration (FDA)	FDAAA 801 / 42 CFR Part 11	Legal and regulatory requirements for trial registration and results reporting (ClinicalTrials.gov)
   Europe (EU)	European Medicines Agency (EMA)	Clinical Trials Regulation (EU No 536/2014)	Harmonizes clinical trial conduct and transparency across the EU (Clinical Trials Information System)
   International	World Health Organization (WHO)	ICTRP	International standards for clinical trial registration and results disclosure (International Clinical Trials Registry Platform)

We will continue to conduct the clinical trial appropriately and as efficiently as possible, and disclose information promptly when it becomes publicly shareable.

We release video briefings for institutional investors on a semiannual basis. These are scheduled for publication in early March and early September.