臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 25, 2022
Last modified on	June. 14, 2023
Trial ID	jRCT2021220032

Scientific Title	A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis
Public Title	Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

Contact for Scientific Queries	Name	Yamada Hiroyuki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com
Contact for Public Queries	Name	Yamada Hiroyuki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 11, 2022
Actual date of first enrollment		Oct. 11, 2022
Target sample size		25
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	- Participant must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301. - Participant must be deemed by the investigator to benefit from secukinumab therapy. - Signed informed consent must be obtained prior to participation in the study
	Exclusion Criteria	- Any participant taking other concomitant biologic immunomodulating agent(s) except secukinumab. - Pregnant or nursing (lactating) women - Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Lupus Nephritis
Intervention(s)		Secukinumab 300 mg solution for s.c. injection in a 2mL Pre-Filled Syringe (PFS)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Proportion of participants achieving Complete Renal Response (CRR) [ Time Frame: 3 years (starting at W104 / end of treatment in CORE study CAIN457Q12301) ]: Proportion of participants achieving protocol-defined CRR
Secondary Outcome(s)

Primary Sponsor	Novartis Pharma. K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tohoku University Hospital IRB
Address	1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
Telephone	+81-22-717-7056
E-Mail	chiken@chiken.hosp.tohoku.ac.jp
Approval Status	Approval
Date of approval	July. 26, 2022

Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Plan to share IPD

Yes

Plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Secondary ID(s)	NCT05232864
Issuing Authority	Clinical Traials.gov

Countries of Recruitment（Except Japan）	Czech Republic/Thailand/Spain/Australia

History of Changes

No	Publication date
2	June. 14, 2023	(this page)	Changes
1	Nov. 25, 2022	Detail

List of change history