Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05639114

PHASE3

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

436

Start Date

2023-03-02

Completion Date

2029-03-21

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

Ianalumab

ianalumab s.c. monthly or quarterly

DRUG

Placebo

placebo s.c. monthly

Inclusion Criteria: * Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed. * Diagnosis of systemic lupus erythematosus meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening. * Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern. * Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol. * SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome" * BILAG-2004 disease activity level at screening of at least 1 of the following: * BILAG-2004 level 'A' disease in ≥ 1 organ system, Or * BILAG-2004 level 'B' disease in ≥ 2 organ systems * Weigh at least 35 kg at screening Exclusion Criteria: * Prior treatment with ianalumab * History of receiving following treatment: I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening. II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower). IV) Traditional Chinese medicines administered within 30 days prior to randomization. * Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection * Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) * Evidence of active tuberculosis infection * History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening * Any one of the following abnormal laboratory values prior to randomization * Platelets \< 25000/mm\^3 (\< 25 x 10\^3/μL) * Hemoglobin (Hgb) \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia * Absolute neutrophil count (ANC) (\< 0.8 x 10\^3/ μL) * Severe organ dysfunction or life-threatening disease at screening * Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment at screening * Receipt of live/attenuated vaccine within a 4-week period before first dosing * Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms * Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS * History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer * Pregnant or nursing (lactating) women. * Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug. * Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

Locations (135)

Pinnacle Research Group Llc

Anniston, Alabama, United States

Providence Medical Center

Burbank, California, United States

University of California San Diego

La Jolla, California, United States

Millennium Clinical Trials

Westlake Village, California, United States

University of Colorado

Aurora, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Clinical Res Of W Florida

Clearwater, Florida, United States

GNP Research

Cooper City, Florida, United States

Clinical Research of West Florida Inc

Tampa, Florida, United States

Parris and Associates Rheumatology

Lawrenceville, Georgia, United States

Chicago Clinical Research Inst

Chicago, Illinois, United States

Robert A Hozman MD SC

Skokie, Illinois, United States

Lake Cumberland Rheumatology and In

New Albany, Indiana, United States

Henry Ford Health

Detroit, Michigan, United States

Sahni Rheumatology and Therapy

West Long Branch, New Jersey, United States

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Shelby Research LLC

Memphis, Tennessee, United States

Accurate Clinical Research Research

Baytown, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Accurate Clinical Research

League City, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Curitiba, Paraná, Brazil

Novartis Investigative Site

Recife, Pernambuco, Brazil

Novartis Investigative Site

Niterói, Rio de Janeiro, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Salvador, Brazil

Novartis Investigative Site

Plovdiv, Bulgaria

Novartis Investigative Site

Rousse, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Rimouski, Quebec, Canada

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Shantou, Guangdong, China

Novartis Investigative Site

Haikou, Hainan, China

Novartis Investigative Site

Zhuzhou, Hunan, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Suzhou, Jiangsu, China

Novartis Investigative Site

Nanchang, Jiangxi, China

Novartis Investigative Site

Pingxiang, Jiangxi, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Linyi, Shandong, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Ürümqi, Xinjiang, China

Novartis Investigative Site

Ningbo, Zhejiang, China

Novartis Investigative Site

Wenzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Xinxiang, China

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Uherské Hradiště, Czechia

Novartis Investigative Site

Guatemala City, Guatemala

Novartis Investigative Site

Guatemala City, Guatemala

Novartis Investigative Site

Székesfehérvár, Fejér, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Gyula, Hungary

Novartis Investigative Site

Zalaegerszeg, Hungary

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa-ku, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Fuchū, Tokyo, Japan

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Novartis Investigative Site

Meguro City, Tokyo, Japan

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Miyazaki, Japan

Novartis Investigative Site

Osaka, Japan

Novartis Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Novartis Investigative Site

Bydgoszcz, Poland

Novartis Investigative Site

Bydgoszcz, Poland

Novartis Investigative Site

Bytom, Poland

Novartis Investigative Site

Lodz, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Braga, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Vila Nova de Gaia, Portugal

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Pretoria, Gauteng, South Africa

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Novartis Investigative Site

Stellenbosch, Western Cape, South Africa

Novartis Investigative Site

Umhlanga, South Africa

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Elche, Alicante, Spain

Novartis Investigative Site

Badalona, Barcelona, Spain

Novartis Investigative Site

Santander, Cantabria, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

San Sebastian Reyes, Madrid, Spain

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Vigo, Pontevedra, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Valladolid, Spain

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Novartis Investigative Site

Muang, Thailand, Thailand

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Ankara, Bilkent Cankaya, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Etlik, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Umraniye, Turkey (Türkiye)

Clinical Research Directory

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (135)