Clinical trial NCT05232864: Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
secukinumab (AIN457)
estimated glomerular filtration rate
Urine Protein-to-Creatinine Ratio
Standard of Care background therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Percentage of Participants Achieving Complete Renal Response (CRR)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
state: VNM
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: