Actively Recruiting

Phase 3
Age: 18Years - 100Years
All Genders
NCT06711887

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Led by Novartis Pharmaceuticals · Updated on 2026-03-11

315

Participants Needed

25

Research Sites

373 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this 2-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.

CONDITIONS

Official Title

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before joining the extension study
  • Completed the entire treatment in the SIRIUS-LN core study up to Week 144 on double-blind or open-label treatment
Not Eligible

You will not qualify if you...

  • Use of therapies not allowed in this study
  • Pregnant or nursing (lactating) women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil, 40150 150

Actively Recruiting

2

Novartis Investigative Site

Shantou, Guangdong, China, 515000

Active, Not Recruiting

3

Novartis Investigative Site

Liuzhou, Guangxi, China, 545005

Actively Recruiting

4

Novartis Investigative Site

Wuhan, Hubei, China, 430060

Actively Recruiting

5

Novartis Investigative Site

Binzhou, Shandong, China, 256603

Actively Recruiting

6

Novartis Investigative Site

Beijing, China, 100034

Actively Recruiting

7

Novartis Investigative Site

Guangzhou, China, 510080

Actively Recruiting

8

Novartis Investigative Site

Guangzhou, China, 510280

Actively Recruiting

9

Novartis Investigative Site

Shanghai, China, 200080

Actively Recruiting

10

Novartis Investigative Site

Barranquilla, Atlántico, Colombia, 080020

Actively Recruiting

11

Novartis Investigative Site

Budapest, Hungary, H-1097

Actively Recruiting

12

Novartis Investigative Site

León, Guanajuato, Mexico, 37160

Actively Recruiting

13

Novartis Investigative Site

Oaxaca City, Mexico, 68020

Actively Recruiting

14

Novartis Investigative Site

Querétaro, Mexico, 76070

Actively Recruiting

15

Novartis Investigative Site

Bucharest, Romania, 022328

Actively Recruiting

16

Novartis Investigative Site

Singapore, Singapore, 169608

Actively Recruiting

17

Novartis Investigative Site

Singapore, Singapore, S308433

Actively Recruiting

18

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

19

Novartis Investigative Site

Seoul, South Korea, 03722

Actively Recruiting

20

Novartis Investigative Site

Seoul, South Korea, 04763

Actively Recruiting

21

Novartis Investigative Site

Taichung, Taiwan, 40447

Actively Recruiting

22

Novartis Investigative Site

Songkhla, Hat Yai, Thailand, 90110

Actively Recruiting

23

Novartis Investigative Site

Bangkok, Thailand, 10330

Actively Recruiting

24

Novartis Investigative Site

Bangkok, Thailand, 10400

Actively Recruiting

25

Novartis Investigative Site

Chiang Mai, Thailand, 50200

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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