Status:
TERMINATED
Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 dat...
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 c...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05232864
Start Date
August 22 2022
End Date
August 23 2023
Last Update
May 16 2025
Active Locations (18)
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1
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
2
Novartis Investigative Site
Fortaleza, Ceará, Brazil, 60430 370
3
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
4
Novartis Investigative Site
Barranquilla, Colombia, 080020