Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

JRCT ID: jRCT2021220032

Registered date:25/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lupus Nephritis
• Date of first enrollment: 11/10/2022
• Target sample size: 25
• Countries of recruitment: Czech Republic,Japan,Thailand,Japan,Spain,Japan,Australia,Japan
• Study type: Interventional
• Intervention(s): Secukinumab 300 mg solution for s.c. injection in a 2mL Pre-Filled Syringe (PFS)

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT05232864