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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05232864
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).

Key Dates

Start date
Aug 22, 2022
Status verified
May 2025
Primary completion
Aug 23, 2023
Completion
Aug 23, 2023

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Percentage of Participants Achieving Complete Renal Response (CRR) [ Time Frame: 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. ]

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