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

NCT05232864 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457Q12301E12021-005772-19
• Study Type: interventional
• Target: 31
• Locations: 13 countries
• Sites: 18

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).

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis; secukinumab (AIN457); estimated glomerular filtration rate; Urine Protein-to-Creatinine Ratio; Standard of Care background therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (1)

Secukinumab

EXPERIMENTAL

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

Drug: Secukinumab

Interventions

Secukinumab DRUG

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

Also known as: AIN457

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Fortaleza, Ceará, 60430 370, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05403 000, Brazil

Location

Novartis Investigative Site

Barranquilla, 080020, Colombia

Location

Novartis Investigative Site

Prague, 128 50, Czechia

Location

Novartis Investigative Site

Prague, 12808, Czechia

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01011, Guatemala

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Lipa City, Batangas, 4217, Philippines

Location

Novartis Investigative Site

Coimbra, 3000 075, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Piešťany, 92101, Slovakia

Location

Novartis Investigative Site

Seoul, 04763, South Korea

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Ho Chi Minh City, VNM, 700000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 41092316 DERIVED

Related Links

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

MeSH Terms

Conditions

Lupus Nephritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: August 22, 2022
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: May 16, 2025
• Results First Posted: August 30, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

VN (1); KR (1); CZ (2); JP (2); SL (1); TH (1); GU (2); AU (1); PH (1); BR (2); CO (1); PT (2); ES (1)