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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05232864

Collaborator

(none)

300

Enrollment

Arm

77.2

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: Secukinumab	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

3 year, open label extension study from CORE CAIN457Q123013 year, open label extension study from CORE CAIN457Q12301

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Aug 4, 2022

Anticipated Primary Completion Date :

Nov 10, 2028

Anticipated Study Completion Date :

Jan 8, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Secukinumab Secukinumab 300 mg solution for s.c. injection in a 2mL Pre-Filled Syringe (PFS)	Drug: Secukinumab STUDY DRUG Other Names: AIN457

Arm

Intervention/Treatment

Experimental: Secukinumab

Secukinumab 300 mg solution for s.c. injection in a 2mL Pre-Filled Syringe (PFS)

Drug: Secukinumab

STUDY DRUG

Other Names:

AIN457

Outcome Measures

Primary Outcome Measures

Proportion of participants achieving Complete Renal Response (CRR) [3 years (starting at W104 / end of treatment in CORE study CAIN457Q12301)]
Proportion of participants achieving protocol-defined CRR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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