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

NCT ID: NCT05232864

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2023-08-23

Brief Summary

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).

Detailed 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.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secukinumab

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

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

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

Interventions

Secukinumab

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

Intervention Type: DRUG

Other Intervention Names

AIN457

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Barranquilla, , Colombia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Lipa City, Batangas, Philippines

Novartis Investigative Site

Coimbra, , Portugal

Novartis Investigative Site

Porto, , Portugal

Novartis Investigative Site

Piešťany, , Slovakia

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Ho Chi Minh City, VNM, Vietnam

Countries

Australia; Brazil; Colombia; Czechia; Guatemala; Japan; Philippines; Portugal; Slovakia; South Korea; Spain; Thailand; Vietnam

References

Zhao MH, Cons Molina F, Aroca G, Tektonidou MG, Mathur A, Tangadpalli R, Sun R, Martin R, Pellet P, Ngoc Phuong Huynh T. Secukinumab in active lupus nephritis: Results from phase III, randomised, placebo-controlled study (SELUNE) and open-label extension study. Rheumatology (Oxford). 2025 Oct 15:keaf536. doi: 10.1093/rheumatology/keaf536. Online ahead of print.

Reference Type: DERIVED

PMID: 41092316 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2284

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

2021-005772-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457Q12301E1

Identifier Type: -

Identifier Source: org_study_id