AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3SIRIUS-SLE LTENCT06133972

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

A Phase 3 study testing Ianalumab in people with Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 164 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 12 to 100 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Ianalumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
164 sitesin 29 countries
Study dates
21 May 2024to 2 Oct 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

164 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

164 sites in 29 countries

United States25 sites, 21 recruiting

  • Pinnacle Research Group Llc

    Anniston, Alabama, 36207

    Ruby Fields, +1 256 236 0055, rfields@pinnacletrials.com

    Vishala L Chindalore

    Recruiting

  • University of Colorado Denver

    Aurora, Colorado, 80045

    Chong Pedrick, chong.pedrick@cuanschutz.edu

    Christopher Striebich

    Recruiting

  • University Of Maryland

    Baltimore, Maryland, 21201

    Active, not recruiting

  • Novel Research LLC

    Bellaire, Texas, 77401

    Hassan Khan, khan@novelresearch.net

    Wajeeha Yousaf

    Recruiting

  • Providence Medical Center

    Burbank, California, 91505

    Sandra Figueroa, +1 818 869 7067, Sandra.Figueroa@providence.org

    Sue Chung

    Recruiting

  • Clinical Res Of W Florida

    Clearwater, Florida, 33765

    Jessica Mayfield, +1 727 466 0078, JMayfield@crwf.com

    Robert Levin

    Recruiting

  • GNP Research

    Cooper City, Florida, 33024

    Melissa Pierce, +1 754 248 3589, melissa@gnpresearch.com

    Mark Jaffe

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Jenna Hudy, +1 313 916 1984, jhudy1@hfhs.org

    Alireza Meysami

    Recruiting

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

    Iman Abdelrahman, +1 810 953 8700, iman@aamrc.net

    Ali Karrar

    Recruiting

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

    Mario Hernandez, 13052460873, mhernandez@associatesinresearch.com

    Gilberto Seco

    Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

    Rachel Williams, 17316330119, rwilliams@arthritisclinic.org

    Jacob A Aelion

    Recruiting

  • Advanced Medical Research

    La Palma, California, 90623

    Reza Azadegan, +1 714 752 6587, razadegan@advmedresearch.com

    Gerald Ho

    Recruiting

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70601

    Machell Broussard, mbroussard@accurateclinicalresearch.com

    Enrique Mendez

    Recruiting

  • Parris and Associates Rheumatology

    Lawrenceville, Georgia, 30044

    Mannai Coutermarsh, +17709621616#8334, m.coutermarsh@parrisandassociates.net

    Glenn Parris

    Recruiting

  • Accurate Clinical Research

    League City, Texas, 77573

    Mariela Martinez, +1 281 422 7179, mmartinez@accurateclinicalresearch.com

    Sabeen Najam

    Recruiting

  • Shelby Research LLC

    Memphis, Tennessee, 38119

    Suvarna Konangula, +1 901 681 9670, shelbyres1999@outlook.com

    Ramesh C Gupta

    Recruiting

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio, 44130

    Denine Ryan, +1 440 891 9395, deniner64@gmail.com

    Isam Diab

    Recruiting

  • UMC New Orleans

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Kathryn Lemon, kal128@pitt.edu

    Andreea Coca

    Recruiting

  • IRIS Research and Development

    Plantation, Florida, 33324

    Jhon Galindo, +1 954 476 2338, jgalindo@irisrheumatology.com

    Guillermo Valenzuela

    Recruiting

  • Epic Medical Research

    Red Oak, Texas, 75154

    Harshini Potluri, +1 469 206 2642, hpotluri@epicmedresearch.com

    Sunny Patel

    Recruiting

  • Robert A Hozman MD SC

    Skokie, Illinois, 60076

    Completed

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33603

    Abby Carlson, +1 813 870 1292, ACarlson@crwf.com

    John Carter

    Recruiting

  • Millennium Clinical Trials

    Westlake Village, California, 91361

    Active, not recruiting

  • Willow Rheumatology Wellness

    Willowbrook, Illinois, 60527

    Lubna Ali, lali@willowrheum.com

    Angela R Crowley

    Recruiting

Other trials in United States

China17 sites, 16 recruiting

  • Novartis Investigative Site

    Beijing, 100069

    Recruiting

  • Novartis Investigative Site

    Beijing, 100730

    Recruiting

  • Novartis Investigative Site

    Changchun, Jilin, 130021

    Recruiting

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

    Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000

    Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

    Recruiting

  • Novartis Investigative Site

    Linyi, Shandong, 276000

    Recruiting

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

    Active, not recruiting

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008

    Recruiting

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016

    Recruiting

  • Novartis Investigative Site

    Pingxiang, Jiangxi, 337000

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200001

    Recruiting

  • Novartis Investigative Site

    Shantou, Guangdong, 515000

    Recruiting

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

    Recruiting

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

    Recruiting

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Novartis Investigative Site

    Xinxiang, 453099

    Recruiting

Other trials in China

India11 sites, 11 recruiting

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380006

    Recruiting

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015

    Recruiting

  • Novartis Investigative Site

    Kolhāpur, Maharashtra, 416001

    Recruiting

  • Novartis Investigative Site

    Kozhikode, Kerala, 673008

    Recruiting

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108

    Recruiting

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101

    Recruiting

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

    Recruiting

  • Novartis Investigative Site

    New Delhi, New Delhi, 110029

    Recruiting

  • Novartis Investigative Site

    New Delhi, 110075

    Recruiting

  • Novartis Investigative Site

    Pune, Maharashtra, 411001

    Recruiting

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

    Recruiting

Other trials in India

Japan11 sites, 4 recruiting

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519

    Recruiting

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1048560

    Recruiting

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838524

    Active, not recruiting

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610

    Active, not recruiting

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510

    Active, not recruiting

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578511

    Active, not recruiting

  • Novartis Investigative Site

    Osaka, 5458586

    Recruiting

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648

    Active, not recruiting

  • Novartis Investigative Site

    Sendai, Miyagi, 9838512

    Recruiting

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582

    Active, not recruiting

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004

    Active, not recruiting

Other trials in Japan

Brazil9 sites, 5 recruiting

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

    Recruiting

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

    Active, not recruiting

  • Novartis Investigative Site

    Niterói, Rio de Janeiro, 24020-096

    Active, not recruiting

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22211-230

    Recruiting

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150-150

    Recruiting

  • Novartis Investigative Site

    Salvador, 40323-010

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030

    Active, not recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002

    Active, not recruiting

  • Novartis Investigative Site

    Vitória, Espírito Santo, 29055-450

    Recruiting

Other trials in Brazil

Spain8 sites, 8 recruiting

  • Novartis Investigative Site

    Badalona, Barcelona, 08916

    Recruiting

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

    Recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    San Sebastian Reyes, Madrid, 28702

    Recruiting

  • Novartis Investigative Site

    Santander, Cantabria, 39008

    Recruiting

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706

    Recruiting

  • Novartis Investigative Site

    Valencia, 46014

    Recruiting

Other trials in Spain

Argentina7 sites, 3 recruiting

  • Novartis Investigative Site

    Caba, C1015ABO

    Active, not recruiting

  • Novartis Investigative Site

    Caba, C1427CCL

    Recruiting

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

    Recruiting

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878

    Recruiting

  • Novartis Investigative Site

    San Miguel, Buenos Aires, B1663GKT

    Active, not recruiting

  • Novartis Investigative Site

    San Miguel, Tucumán Province, T4000CBC

    Active, not recruiting

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL

    Active, not recruiting

Other trials in Argentina

Colombia6 sites, 1 recruiting

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

    Active, not recruiting

  • Novartis Investigative Site

    Bogotá, 111211

    Active, not recruiting

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003

    Active, not recruiting

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760046

    Recruiting

  • Novartis Investigative Site

    Chía, Cundinamarca, 250001

    Active, not recruiting

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

    Active, not recruiting

Other trials in Colombia

Mexico6 sites, 2 recruiting

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44160

    Active, not recruiting

  • Novartis Investigative Site

    León, Guanajuato, 37160

    Recruiting

  • Novartis Investigative Site

    Mérida, Yucatán, 97070

    Recruiting

  • Novartis Investigative Site

    México, 07760

    Active, not recruiting

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

    Active, not recruiting

  • Novartis Investigative Site

    Morelia, Michoacán, 58000

    Active, not recruiting

Other trials in Mexico

Poland6 sites, 6 recruiting

  • Novartis Investigative Site

    Bydgoszcz, 85-065

    Recruiting

  • Novartis Investigative Site

    Bydgoszcz, 85-168

    Recruiting

  • Novartis Investigative Site

    Bytom, 41 902

    Recruiting

  • Novartis Investigative Site

    Warsaw, 00-874

    Recruiting

  • Novartis Investigative Site

    Warsaw, 04-141

    Recruiting

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-210

    Recruiting

Other trials in Poland

Taiwan6 sites, 6 recruiting

  • Novartis Investigative Site

    Kaohsiung City, 833

    Recruiting

  • Novartis Investigative Site

    Taichung, 40447

    Recruiting

  • Novartis Investigative Site

    Taichung, 407219

    Recruiting

  • Novartis Investigative Site

    Taipei, 10002

    Recruiting

  • Novartis Investigative Site

    Taipei, 11217

    Recruiting

  • Novartis Investigative Site

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

France5 sites, 3 recruiting

  • Novartis Investigative Site

    Montpellier, 34295

    Recruiting

  • Novartis Investigative Site

    Paris, 75013

    Active, not recruiting

  • Novartis Investigative Site

    Paris, 75014

    Active, not recruiting

  • Novartis Investigative Site

    Toulouse, 31054

    Recruiting

  • Novartis Investigative Site

    Toulouse, 31059

    Recruiting

Other trials in France

Italy5 sites, 5 recruiting

  • Novartis Investigative Site

    Cona, FE, 44124

    Recruiting

  • Novartis Investigative Site

    Padova, PD, 35128

    Recruiting

  • Novartis Investigative Site

    Pisa, PI, 56126

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00152

    Recruiting

  • Novartis Investigative Site

    Torino, TO, 10128

    Recruiting

Other trials in Italy

South Africa5 sites, 5 recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape, 7405

    Recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500

    Recruiting

  • Novartis Investigative Site

    Pretoria, Gauteng, 0002

    Recruiting

  • Novartis Investigative Site

    Somerset West, Western Cape, 7130

    Recruiting

  • Novartis Investigative Site

    Umhlanga, 4320

    Recruiting

Other trials in South Africa

Hungary4 sites, 4 recruiting

  • Novartis Investigative Site

    Budapest, 1134

    Recruiting

  • Novartis Investigative Site

    Gyula, 5700

    Recruiting

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000

    Recruiting

  • Novartis Investigative Site

    Zalaegerszeg, 8900

    Recruiting

Other trials in Hungary

Thailand4 sites, 4 recruiting

  • Novartis Investigative Site

    Bangkok, 10400

    Recruiting

  • Novartis Investigative Site

    Bangkok, 10700

    Recruiting

  • Novartis Investigative Site

    Muang, Thailand, 12120

    Recruiting

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110

    Recruiting

Other trials in Thailand

Canada3 sites, 2 recruiting

  • Novartis Investigative Site

    Rimouski, Quebec, G5L 5T1

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8

    Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7

    Active, not recruiting

Other trials in Canada

Chile3 sites, 3 recruiting

  • Novartis Investigative Site

    Santiago, RM, 7500588

    Recruiting

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500710

    Recruiting

  • Novartis Investigative Site

    Valdivia, Los Ríos Region, 5110683

    Recruiting

Other trials in Chile

Czechia3 sites, 3 recruiting

  • Novartis Investigative Site

    Brno, 638 00

    Recruiting

  • Novartis Investigative Site

    Prague, 128 00

    Recruiting

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

    Recruiting

Other trials in Czechia

Romania3 sites, 3 recruiting

  • Novartis Investigative Site

    Brasov, 500283

    Recruiting

  • Novartis Investigative Site

    Bucharest, 011172

    Recruiting

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006

    Recruiting

Other trials in Romania

South Korea3 sites, 3 recruiting

  • Novartis Investigative Site

    Gwangju, 61469

    Recruiting

  • Novartis Investigative Site

    Seoul, 04763

    Recruiting

  • Novartis Investigative Site

    Seoul, 06591

    Recruiting

Other trials in South Korea

Bulgaria2 sites, 2 recruiting

  • Novartis Investigative Site

    Plovdiv, Bulgaria, 4002

    Recruiting

  • Novartis Investigative Site

    Sofia, 1431

    Recruiting

Other trials in Bulgaria

Germany2 sites, 1 recruiting

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

    Withdrawn

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

    Recruiting

Other trials in Germany

Guatemala2 sites, 2 recruiting

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010

    Recruiting

  • Novartis Investigative Site

    Guatemala City, 01010

    Recruiting

Other trials in Guatemala

Israel2 sites, 1 recruiting

  • Novartis Investigative Site

    Haifa, 3109601

    Active, not recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601

    Recruiting

Other trials in Israel

Portugal2 sites, 2 recruiting

  • Novartis Investigative Site

    Braga, 4710-243

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1050-034

    Recruiting

Other trials in Portugal

Slovakia2 sites

  • Novartis Investigative Site

    Bratislava, 811 08

    Active, not recruiting

  • Novartis Investigative Site

    Košice, 040 01

    Active, not recruiting

Other trials in Slovakia

Australia1 site, 1 recruiting

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

    Recruiting

Other trials in Australia

Malaysia1 site, 1 recruiting

  • Novartis Investigative Site

    Ipoh, Perak, 30450

    Recruiting

Other trials in Malaysia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, 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).

Read the 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.

This extension study will last up to 7 years and includes the following three treatment periods:

  • a 3-year double-blind, randomized, placebo-controlled treatment period, evaluating the safety and efficacy of ianalumab or placebo (Period 1);
  • followed by a 2-year treatment period evaluating safety and efficacy of treatment withdrawal and open-label ianalumab administered s.c. monthly.
  • and an up to 2-year open-label, safety monitoring period (Period 3).
Being tested
Placebo, Ianalumab
Keywords
Systemic Lupus Erythematosus, SLE, B cell depletion, SLEDAI-2K, BILAG-2004, SRI-4, ANA, ianalumab, VAY736
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo s.c. monthly

  • IanalumabDrug

    Also called VAY736

    Ianalumab s.c. monthly Ianalumab s.c. quarterly

Study groups in NCT06133972
Study groupRoleWhat they receive
Ianalumab monthlyExperimentalIanalumab s.c. monthly
Receives: Drug: Ianalumab
Ianalumab quarterlyExperimentalIanalumab s.c. quarterly
Receives: Drug: Ianalumab
Placebo monthlyPlacebo comparatorPlacebo s.c. monthly
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment-emergent Adverse events/Serious Adverse events

    Assessment of long-term safety and tolerability of ianalumab

    Measured: through study completion, up to approximately 324 weeks

Secondary outcomes (7)

  1. Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response

    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

    Measured: up to Week 324

  2. Proportion of participants who achieved Definition of Remission in SLE (DORIS) response

    DORIS is defined as:

    • Clinical SLEDAI (cSLEDAI) = 0 (excluding serological items, anti-dsDNA and complement)
    • Physician global assessment (PhGA, scale 0-3) < 0.5
    • Current CS (predniso(lo)ne or equivalent) dose ≤ 5 mg/day
    • Patient may be on antimalarials, low dose glucocorticoids and/or stable immune-suppressive treatment including biologics.

    Measured: up to Week 324

  3. Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index

    SLICC/ACR Damage Index is a measure of cumulative damage due to SLE

    Measured: up to Week 324

  4. Average daily dose of corticosteroids administered

    Evaluating the effect of ianalumab on corticosteroids intake

    Measured: up to Week 324

  5. Annualized BILAG moderate or severe flare rate

    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

    Measured: up to Week 324

  6. Ianalumab serum concentrations during treatment and follow-up after last dose

    To characterize the Pharmacokinetics (PK) of ianalumab

    Measured: up to Week 324

  7. Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time.

    To characterize the immunogenicity of ianalumab

    Measured: up to Week 324

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start21 May 2024
  3. Primary completion3 Apr 2034 (estimated)
  4. Study completion2 Oct 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial is designed to evaluate long-term safety, tolerability and efficacy of two regimen of ianalumab versus placebo, given as monthly or quarterly subcutaneous (s.c.) injection. After the 3 year randomized, placebo-controlled period the study will continue as open-label to evaluate long term safety and efficacy of ianalumab, on or off-treatment, for an additional two years, followed by further monitoring of longer-term safety for up to two additional years
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133972
Sponsor's protocol ID
CVAY736F12301E1
Other IDs
2023-505929-14-00, 2023
Acronym
SIRIUS-SLE LTE
Status last verified
Oct 2026
First submitted
2 Oct 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ianalumab in people with Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 164 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, China, India, Japan, Brazil and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment-emergent Adverse events/Serious Adverse events (time frame: through study completion, up to approximately 324 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06133972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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SIRIUS-SLE LTE Clinical Trial NCT06133972 | AzTrials