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

Phase 3TerminatedNCT05232864

Novartis Pharmaceuticals31 enrolled

Overview

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).

Investigators used their clinical judgement to decide if it might be beneficial, in terms of overall improvement and response to therapy, for subjects to enter the extension study. The planned total combined duration for the core study and this extension study was five years. At Week 104 of the core study CAIN457Q12301, eligible subjects who completed the assessments associated with the core study visit subsequently continued in the extension study on the dose of secukinumab 300 mg administered every four weeks. A total of 31 subjects were enrolled and received secukinumab 300 mg every four weeks until study termination. Recruitment in this study was stopped on 26-May-2023. This study along with the core study (CAIN457Q12301) were terminated early by Novartis due to futile results of interim analysis 1 of the core study. There were no safety related reasons for early termination of either of the studies.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis

Interventions

SecukinumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key inclusion criteria: * Subject must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301. * Subject 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 subject taking other concomitant biologic immunomodulating agent(s) except secukinumab. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. * 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 (e.g., in European Union (EU) 20 Weeks). Highly effective methods of contraception are recommended due to the known teratogenic effect of SoC (MPA).

Locations (18)

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Outcomes

Primary Outcomes

Percentage of Participants Achieving Complete Renal Response (CRR)

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.

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.

Data from ClinicalTrials.gov

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