Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

NCT05624749 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: CVAY736F123022022-002690-292023-508499-12-00
• Study Type: interventional
• Target: 288
• Locations: 15 countries
• Sites: 95

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, SLE, B cell depletion, SLEDAI-2K, BILAG-2004, SRI, ANA

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)

  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

  Week 60

Secondary Outcomes (11)

• Proportion of participants with no moderate or severe BILAG flare

  Baseline to Week 60

• Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid (CS) dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower

  Week 36 to Week 60

• Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)

  Week 60

• Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

  Week 60

• Time to first occurrence of SRI-4

  Baseline to Week 60

Study Arms (2)

ianalumab s.c. monthly

EXPERIMENTAL

ianalumab s.c. monthly

Drug: ianalumab

placebo s.c. monthly

PLACEBO COMPARATOR

placebo s.c. monthly

Drug: placebo

Interventions

ianalumab DRUG

ianalumab s.c. monthly

Also known as: VAY736

ianalumab s.c. monthly

placebo DRUG

placebo s.c. monthly

placebo s.c. monthly

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior treatment with ianalumab
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (95)

Pinnacle Research Group LLC

Anniston, Alabama, 36207-5710, United States

Location

Advanced Medical Research

La Palma, California, 90623, United States

Location

University of California LA

Los Angeles, California, 90095, United States

Location

Homestead Assoc In Research Inc

Homestead, Florida, 33033, United States

Location

IRIS Research and Development

Plantation, Florida, 33324, United States

Location

Emory University

Atlanta, Georgia, 30307, United States

Location

Willow Rheumatology Wellness

Willowbrook, Illinois, 60527, United States

Location

Bluegrass Community Research Inc

Lexington, Kentucky, 40504, United States

Location

Accurate Clinical Research

Lake Charles, Louisiana, 70601, United States

Location

UMC New Orleans

New Orleans, Louisiana, 70112, United States

Location

University Of Maryland

Baltimore, Maryland, 21201, United States

Location

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, 48439, United States

Location

Washington Univ School Of Medicine

St Louis, Missouri, 63110, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Novel Research LLC

Bellaire, Texas, 77401, United States

Location

Novartis Investigative Site

La Plata, Buenos Aires, B1900AWT, Argentina

Location

Novartis Investigative Site

Quilmes, Buenos Aires, 1878, Argentina

Location

Novartis Investigative Site

San Miguel, Buenos Aires, B1663GKT, Argentina

Location

Novartis Investigative Site

San Miguel, Tucumán Province, T4000CBC, Argentina

Location

Novartis Investigative Site

Caba, C1015ABO, Argentina

Location

Novartis Investigative Site

Caba, C1426, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

Location

Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

Location

Novartis Investigative Site

St Leonards, 2065, Australia

Location

Novartis Investigative Site

Concepción, Bio Bio, 4070280, Chile

Location

Novartis Investigative Site

Valdivia, Los Ríos Region, 5110683, Chile

Location

Novartis Investigative Site

Santiago, RM, 7500588, Chile

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Novartis Investigative Site

Medellín, Antioquia, 050001, Colombia

Location

Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia

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Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

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Novartis Investigative Site

Chía, Cundinamarca, 250001, Colombia

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Novartis Investigative Site

Bucaramanga, Santander Department, 680003, Colombia

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Novartis Investigative Site

Cali, Valle del Cauca Department, 760046, Colombia

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Novartis Investigative Site

Bogotá, 111211, Colombia

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Montpellier, 34295, France

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Novartis Investigative Site

Paris, 75013, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75018, France

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Novartis Investigative Site

Toulouse, 31054, France

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Novartis Investigative Site

Toulouse, 31059, France

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Novartis Investigative Site

Tours, 37044, France

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Ahmedabad, Gujarat, 380006, India

Location

Novartis Investigative Site

Ahmedabad, Gujarat, 380015, India

Location

Novartis Investigative Site

Kozhikode, Kerala, 673008, India

Location

Novartis Investigative Site

Kolhāpur, Maharashtra, 416001, India

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Novartis Investigative Site

Nagpur, Maharashtra, 441108, India

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Novartis Investigative Site

Nashik, Maharashtra, 422101, India

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Novartis Investigative Site

Pune, Maharashtra, 411001, India

Location

Novartis Investigative Site

Pune, Maharashtra, 411007, India

Location

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110060, India

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Novartis Investigative Site

Dehradun, Uttarakhand, 248001, India

Location

Novartis Investigative Site

New Delhi, 110029, India

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Novartis Investigative Site

New Delhi, 110075, India

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Cona, FE, 44124, Italy

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Novartis Investigative Site

Padua, PD, 35128, Italy

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Novartis Investigative Site

Pisa, PI, 56126, Italy

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Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Torino, TO, 10128, Italy

Location

Novartis Investigative Site

Naples, 80147, Italy

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Novartis Investigative Site

Seremban, Negeri Sembilan, 70300, Malaysia

Location

Novartis Investigative Site

Ipoh, Perak, 30450, Malaysia

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Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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Novartis Investigative Site

Selangor Darul Ehsan, 68100, Malaysia

Location

Novartis Investigative Site

León, Guanajuato, 37160, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44160, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Morelia, Michoacán, 58000, Mexico

Location

Novartis Investigative Site

Mérida, Yucatán, 97000, Mexico

Location

Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

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Novartis Investigative Site

México, 07760, Mexico

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Novartis Investigative Site

Cluj-Napoca, Cluj, 400006, Romania

Location

Novartis Investigative Site

Afumaţi, Ilfov, 077010, Romania

Location

Novartis Investigative Site

Brasov, 500283, Romania

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Novartis Investigative Site

Bucharest, 011172, Romania

Location

Novartis Investigative Site

Gwangju Gwangyeoksi, Gwangju, 61748, South Korea

Location

Novartis Investigative Site

Seoul, 04763, South Korea

Location

Novartis Investigative Site

Seoul, 06591, South Korea

Location

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

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Novartis Investigative Site

Taoyuan District, 33305, Taiwan

Location

Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 22, 2022
• Study Start: April 21, 2023
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): April 9, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (16); MY (4); IT (7); FR (8); RO (4); AU (2); CO (7); ME (7); CL (4); KR (3); AR (7); GB (3); TW (6); IN (12); DE (5)