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

Novartis

Status and phase

Terminated

Phase 3

Conditions

Lupus Nephritis

Treatments

Drug: Secukinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05232864

2021-005772-19 (EudraCT Number)

CAIN457Q12301E1

Details and patient eligibility

About

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).

Full description

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).