An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)
Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent prior to participation in the extension study.
• Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.
Locations
United States
New York
Circuit Clinical
RECRUITING
Orchard Park
Other Locations
Brazil
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
RECRUITING
Recife
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
Santo André
Novartis Investigative Site
RECRUITING
Vitória
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Binzhou
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Liuzhou
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shantou
Novartis Investigative Site
RECRUITING
Shenzhen
Novartis Investigative Site
RECRUITING
Wuhan
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
France
Novartis Investigative Site
RECRUITING
Grenoble
Guatemala
Novartis Investigative Site
RECRUITING
Guatemala City
Novartis Investigative Site
RECRUITING
Guatemala City
Novartis Investigative Site
RECRUITING
Quetzaltenango
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Tuenmen
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Sibu
Mexico
Novartis Investigative Site
RECRUITING
León
Novartis Investigative Site
RECRUITING
Oaxaca City
Novartis Investigative Site
RECRUITING
Querétaro
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Suwon
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
Thailand
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Chiang Mai
Novartis Investigative Site
RECRUITING
Songkhla
Viet Nam
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2035-08-01
Participants
Target number of participants: 348
Treatments
No_intervention: Study Treatment Withdrawal (cohort 1)
(Cohort 1): Study Treatment-Withdrawal group. Participants who received blinded study treatment in the core study and achieve CRR or PRR at Week 140 in the core study will enter the extension study and discontinue study treatment while maintaining standard of care (SoC) medication, as required. If renal flare criteria are met, participants will be eligible to receive open-label ianalumab.
Experimental: Open-Label Ianalumab (cohort 2)
(Cohort 2): Open-Label Ianalumab group: Participants who received blinded study treatment throughout the core study and did not achieve CRR or PRR at Week 140 of the core study, or who had switched to open-label ianalumab during the core study, will be eligible or will continue to receive open-label ianalumab in the extension study.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals