Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). (SIRIUS-SLE LTE)

March 11, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Caba, Argentina, C1015ABO
        • Recruiting
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • San Miguel, Buenos Aires, Argentina, B1663GKT
        • Recruiting
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel, Tucumán Province, Argentina, T4000CBC
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Recruiting
        • Novartis Investigative Site
  • Brazil
      • Salvador, Brazil, 40323-010
        • Recruiting
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150 150
        • Recruiting
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Novartis Investigative Site
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22211-230
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784 400
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01244-030
        • Recruiting
        • Novartis Investigative Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L7
        • Active, not recruiting
        • Novartis Investigative Site
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Recruiting
        • Novartis Investigative Site
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Santiago, RM, Chile, 7500588
        • Recruiting
        • Novartis Investigative Site
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500710
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100069
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200127
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Novartis Investigative Site
      • Shantou, Guangdong, China, 515000
        • Recruiting
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Novartis Investigative Site
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Active, not recruiting
        • Novartis Investigative Site
      • Pingxiang, Jiangxi, China, 337000
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Novartis Investigative Site
    • Shandong
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Ningbo, Zhejiang, China, 315016
        • Recruiting
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia, 111211
        • Recruiting
        • Novartis Investigative Site
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Active, not recruiting
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Recruiting
        • Novartis Investigative Site
    • Cundinamarca
      • Chía, Cundinamarca, Colombia, 250001
        • Recruiting
        • Novartis Investigative Site
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680003
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 638 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Recruiting
        • Novartis Investigative Site
      • Uherské Hradiště, Czechia, 686 01
        • Recruiting
        • Novartis Investigative Site
  • France
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75014
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Recruiting
        • Novartis Investigative Site
  • Germany
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Gyula, Hungary, 5700
        • Recruiting
        • Novartis Investigative Site
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Recruiting
        • Novartis Investigative Site
  • India
      • New Delhi, India, 110029
        • Recruiting
        • Novartis Investigative Site
      • New Delhi, India, 110075
        • Recruiting
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Recruiting
        • Novartis Investigative Site
      • Ahmedabad, Gujarat, India, 380006
        • Recruiting
        • Novartis Investigative Site
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 441108
        • Recruiting
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422101
        • Recruiting
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • PI
      • Pisa, PI, Italy, 56126
        • Recruiting
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10128
        • Recruiting
        • Novartis Investigative Site
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4578510
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa-ku
      • Yokohama, Kanagawa-ku, Japan, 236-0004
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 1048560
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • México, Mexico, 07760
        • Recruiting
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, Mexico, 37160
        • Recruiting
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Recruiting
        • Novartis Investigative Site
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Recruiting
        • Novartis Investigative Site
    • Michoacán
      • Morelia, Michoacán, Mexico, 58000
        • Recruiting
        • Novartis Investigative Site
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Recruiting
        • Novartis Investigative Site
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Novartis Investigative Site
      • Bytom, Poland, 41 902
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 00-874
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 04-141
        • Recruiting
        • Novartis Investigative Site
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • Novartis Investigative Site
      • Bucharest, Romania, 011172
        • Recruiting
        • Novartis Investigative Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Recruiting
        • Novartis Investigative Site
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0002
        • Recruiting
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Recruiting
        • Novartis Investigative Site
      • Cape Town, Western Cape, South Africa, 7405
        • Recruiting
        • Novartis Investigative Site
      • Stellenbosch, Western Cape, South Africa, 7600
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Novartis Investigative Site
    • Gwangju
      • Gwangju Gwangyeoksi, Gwangju, South Korea, 61748
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46014
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Recruiting
        • Novartis Investigative Site
    • Madrid
      • San Sebastian Reyes, Madrid, Spain, 28702
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Recruiting
        • Novartis Investigative Site
      • Taoyuan District, Taiwan, 33305
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Pinnacle Research Group Llc
        • Principal Investigator:
          • Vishala L Chindalore
        • Contact:
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Medical Center
        • Principal Investigator:
          • Sue Chung
        • Contact:
      • La Palma, California, United States, 90623
        • Recruiting
        • Advanced Medical Research
        • Principal Investigator:
          • Gerald Ho
        • Contact:
      • Westlake Village, California, United States, 91361
        • Recruiting
        • Millennium Clinical Trials
        • Contact:
        • Principal Investigator:
          • Razmig Krumian
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver
        • Principal Investigator:
          • Christopher Striebich
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Res Of W Florida
        • Principal Investigator:
          • Robert Levin
        • Contact:
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • GNP Research
        • Principal Investigator:
          • Mark Jaffe
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development
        • Contact:
        • Principal Investigator:
          • Guillermo Valenzuela
    • Georgia
      • Lawrenceville, Georgia, United States, 30044
        • Recruiting
        • Parris and Associates Rheumatology
        • Principal Investigator:
          • Glenn Parris
        • Contact:
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Robert A Hozman MD SC
        • Principal Investigator:
          • Robert Hozman
        • Contact:
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology Wellness
        • Principal Investigator:
          • Angela R Crowley
        • Contact:
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Alireza Meysami
        • Contact:
      • Grand Blanc, Michigan, United States, 48439
        • Recruiting
        • Ahmed Arif Medical Research Center
        • Principal Investigator:
          • Ali Karrar
        • Contact:
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Med Rsrch and Consult LLC
        • Principal Investigator:
          • Isam Diab
        • Contact:
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Principal Investigator:
          • Jacob A Aelion
        • Contact:
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Shelby Research LLC
        • Principal Investigator:
          • Ramesh C Gupta
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Novel Research LLC
        • Principal Investigator:
          • Wajeeha Yousaf
        • Contact:
      • League City, Texas, United States, 77573
      • Red Oak, Texas, United States, 75154
        • Recruiting
        • Epic Medical Research
        • Principal Investigator:
          • Sunny Patel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants <18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
  • Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
  • In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Key Exclusion Criteria:

  • Use of prohibited therapies.
  • Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
  • Plans for administration of live vaccines during the study period.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
  • United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ianalumab monthly
Ianalumab s.c. monthly
Drug: Ianalumab
Ianalumab s.c. monthly Ianalumab s.c. quarterly
Other Names:
  • VAY736
Experimental: Ianalumab quarterly
Ianalumab s.c. quarterly
Drug: Ianalumab
Ianalumab s.c. monthly Ianalumab s.c. quarterly
Other Names:
  • VAY736
Placebo Comparator: Placebo monthly
Placebo s.c. monthly
Drug: Placebo
Placebo s.c. monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent Adverse events/Serious Adverse events
Time Frame: through study completion, up to approximately 91 months
Assessment of long-term safety and tolerability of ianalumab
through study completion, up to approximately 91 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response
Time Frame: up to Week 216

SRI-4 response is defined as:

  • Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points
  • No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
  • No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale
up to Week 216
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Time Frame: up to Week 216
SLICC/ACR Damage Index is a measure of cumulative damage due to SLE
up to Week 216
Average daily dose of oral corticosteroids administered
Time Frame: up to Week 216
Evaluating the effect of ianalumab on corticosteroids intake
up to Week 216
Annualized BILAG moderate or severe flare rate
Time Frame: up to Week 216
Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit
up to Week 216

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

April 8, 2030

Study Completion (Estimated)

April 5, 2032

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736F12301E1
  • 2023-505929-14-00 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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