Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
- Registration Number
- NCT05232864
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study CAIN457Q12301 and to obtain long term efficacy, safety and tolerability data
- Detailed Description
This study is an up to three-year open-label extension study to the core study CAIN457Q12301 (a two-year, phase III study that enrolled participants aged 18 to 75 years with active Lupus Nephritis). The aim is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study and opt to continue in to the extension study and to obtain further long-term efficacy, safety and tolerability information. All subjects will receive 300 mg secukinumab s.c. every 4 weeks. Background SoC will consist of maintenance therapy with mycophenolic acid (MPA) and oral corticosteroids at the minimal dose required by the participant's status to maintain response. Participants who the investigator believes will continue to receive benefit from treatment may also have post-trial access until secukinumab is available for LN following product launch/subsequent reimbursement (where applicable), or treatment discontinuation, or the benefit-risk profile is no longer positive.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Secukinumab Secukinumab Secukinumab 300 mg solution for subcutaneous (s.c.) injection in a 2mL Pre-Filled Syringe (PFS)
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Complete Renal Response (CRR) Up to 28 weeks: from enrollment in the extension study (Week 104E1) up to Week 132 or Early termination of the Extension Study. Study day is defined with respect to the core study. Complete Renal Response (CRR) is a composite endpoint defined as:
* Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of core Baseline values and
* 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =\< 0.5mg/mg
The glomerular filtration rate was estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on subject gender, age (years) and serum creatinine (mg/dL). Central laboratory serum creatinine values were used for all renal function data analysis.
UPCR was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected. UPCR was determined using one of the following two types of urine collection, 24-hour urine collection or first morning void urinary sample, both of which were collected in the subjects' home.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇻🇳Ho Chi Minh, VNM, Vietnam