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

Lupus Nephritis Clinical Trial

Official title:

A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05232864
• Other study ID #: CAIN457Q12301E1
• Secondary ID: 2021-005772-19
• Status: Terminated
• Phase: Phase 3
• Start date: August 22, 2022
• Est. completion date: August 23, 2023

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study CAIN457Q12301 and to obtain long term efficacy, safety and tolerability data

Description:

This study is an up to three-year open-label extension study to the core study CAIN457Q12301 (a two-year, phase III study that enrolled participants aged 18 to 75 years with active Lupus Nephritis). The aim is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study and opt to continue in to the extension study and to obtain further long-term efficacy, safety and tolerability information. All subjects will receive 300 mg secukinumab s.c. every 4 weeks. Background SoC will consist of maintenance therapy with mycophenolic acid (MPA) and oral corticosteroids at the minimal dose required by the participant's status to maintain response. Participants who the investigator believes will continue to receive benefit from treatment may also have post-trial access until secukinumab is available for LN following product launch/subsequent reimbursement (where applicable), or treatment discontinuation, or the benefit-risk profile is no longer positive.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion criteria

• Participant must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301.
• Participant 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 participant taking other concomitant biologic immunomodulating agent(s) except secukinumab.
• Pregnant or nursing (lactating) women
• 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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Secukinumab
STUDY DRUG

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Westmead	New South Wales
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Sao Paulo	SP
Colombia	Novartis Investigative Site	Barranquilla
Czechia	Novartis Investigative Site	Prague 2
Czechia	Novartis Investigative Site	Praha
Guatemala	Novartis Investigative Site	Guatemala
Guatemala	Novartis Investigative Site	Guatemala City
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Sendai city	Miyagi
Korea, Republic of	Novartis Investigative Site	Seoul
Philippines	Novartis Investigative Site	Lipa City	Batangas
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Porto
Slovakia	Novartis Investigative Site	Piestany
Spain	Novartis Investigative Site	Barcelona	Catalunya
Thailand	Novartis Investigative Site	Bangkok
Vietnam	Novartis Investigative Site	Ho Chi Minh	VNM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Brazil,  Colombia,  Czechia,  Guatemala,  Japan,  Korea, Republic of,  Philippines,  Portugal,  Slovakia,  Spain,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving Complete Renal Response (CRR)	Proportion of participants achieving protocol-defined CRR	3 years (starting at W104 / end of treatment in CORE study CAIN457Q12301)