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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 3 year, open label extension study from CORE CAIN457Q12301
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>Secukinumab 300 mg solution for s.c. injection in a 2mL Pre-Filled Syringe (PFS) | Drug: Secukinumab<br>* STUDY DRUG<br>* Other names: AIN457;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving Complete Renal Response (CRR) | Proportion of participants achieving protocol-defined CRR | 3 years (starting at W104 / end of treatment in CORE study CAIN457Q12301) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Nephritis, secukinumab (AIN457), estimated glomerular filtration rate, Urine Protein-to-Creatinine Ratio, Standard of Care background therapy