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RECRUITING

NCT05126277

PHASE3

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

462

Start Date

2022-07-14

Completion Date

2031-02-11

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Lupus Nephritis

Interventions

DRUG

ianalumab s.c. q4w

ianalumab s.c. q4w in addition to SoC

DRUG

ianalumab s.c. q12w

ianalumab s.c. q12w in addition to SoC

DRUG

placebo s.c.

placebo s.c. q4w in addition to SoC

Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * Adult male and female participants aged 18 years or older at the time of screening * Weigh at least 35 kg at screening * Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria * Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result * Active LN at screening, as defined by meeting the 3 following criteria: * Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria. * UPCR ≥ 1.0 g/g on 24h urine collection at Screening * eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli * Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA * Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization * Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications * Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization * Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne. * Able to communicate well with the Investigator to understand and comply with the requirements of the study Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study: * Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation * Sclerosis in \> 50% of glomeruli on renal biopsy * Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of certain Traditional Chinese Medicines * Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered \< 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy * Prior treatment with any of the following within 12 weeks prior to randomization * Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis * Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors) * Thalidomide treatment and/or methotrexate * Combination of DMARDs * Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA * Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization * History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation * Any one of the following laboratory values at screening: * Hemoglobin levels \< 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 * Platelet count \< 25 x 1000/µL * Absolute neutrophil count (ANC) \< 0.8 x 1000/µL * Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation. * History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients * Receipt of live/attenuated vaccine within a 4-week period prior to randomization * History of primary or secondary immunodeficiency, including a positive HIV test result * History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases * Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study * Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant * Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines) * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication * Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment Other protocol -defined Inclusion/Exclusion may apply.

Locations (188)

University Of Alabama

Birmingham, Alabama, United States

Advanced Medical Research

La Palma, California, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

University of California LA

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

School Of Medicine

Sacramento, California, United States

University of California San Diego

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University Of Miami

Miami, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Fides Clinical Research

Atlanta, Georgia, United States

Parris and Associates Rheumatology

Lawrenceville, Georgia, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Accurate Clinical Research

Lake Charles, Louisiana, United States

UMC New Orleans

New Orleans, Louisiana, United States

Wayne State University

Detroit, Michigan, United States

Univ of Nevada School of Med

Las Vegas, Nevada, United States

Sahni Rheumatology and Therapy

West Long Branch, New Jersey, United States

VA NM Healthcare System

Albuquerque, New Mexico, United States

NY Nephrology

Clifton Park, New York, United States

Hospital for Special Surgery

New York, New York, United States

Northwell Health

New York, New York, United States

Circuit Clinical

Orchard Park, New York, United States

James J Peters VA Medical Center

The Bronx, New York, United States

Brookview Hills Research Assoc

Winston-Salem, North Carolina, United States

University Of Cincinnati

Cincinnati, Ohio, United States

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Arthritis and Rheumatology Ins

Allen, Texas, United States

Precision Comprehensive Research

Colleyville, Texas, United States

Liberty Research Center

Dallas, Texas, United States

Univof Texas Southwestern Med Cntr

Dallas, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Uni of Texas Health Science Center

San Antonio, Texas, United States

Baylor Scott and White Research

Temple, Texas, United States

Northern Assoc of Northern VA

Fairfax, Virginia, United States

Uni Wisconsin School Med Pub Health

Madison, Wisconsin, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

São Luís, Maranhão, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Recife, Pernambuco, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

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Santo André, São Paulo, Brazil

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Salvador, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Santiago, RM, Chile

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Temuco, Chile

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Hefei, Anhui, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Shantou, Guangdong, China

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Shenzhen, Guangdong, China

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Shenzhen, Guangdong, China

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Liuchow, Guangxi, China

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Haikou, Hainan, China

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Wuhan, Hubei, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Nanchang, Jiangxi, China

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Changchun, Jilin, China

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Shenyang, Liaoning, China

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Binzhou, Shandong, China

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Linyi, Shandong, China

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Xian, Shanxi, China

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Chengdu, Sichuan, China

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Ningbo, Zhejiang, China

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Beijing, China

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Chongqing, China

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Guangzhou, China

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Guangzhou, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Olomouc, Czechia

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Prague, Czechia

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Tallinn, Estonia

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Tallinn, Estonia

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Angers, France

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Besançon, France

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Bordeaux, France

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Grenoble, France

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Lyon, France

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Marseille, France

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Poitiers, France

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Toulouse, France

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Vandœuvre-lès-Nancy, France

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Regensburg, Bavaria, Germany

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Aachen, Germany

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Bochum, Germany

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Münster, Germany

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Guatemala City, Guatemala

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Guatemala City, Guatemala

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Quetzaltenango, Guatemala

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Kwun Tong, Kowloon, Hong Kong

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Tuenmen, Hong Kong

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Kaposvár, Hungary

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Bangalore, Karnataka, India

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Secunderabad, Telangana, India

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Secunderabad, Telangana, India

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Lucknow, Uttar Pradesh, India

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Chandigarh, India

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Cagliari, CA, Italy

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Foggia, FG, Italy

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Florence, FI, Italy

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Milan, MI, Italy

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Pavia, PV, Italy

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Roma, RM, Italy

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Torino, TO, Italy

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Udine, UD, Italy

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Naples, Italy

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Kaunas, LTU, Lithuania

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Vilnius, Lithuania

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Sibu, Sarawak, Malaysia

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Kuala Terengganu, Terengganu, Malaysia

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León, Guanajuato, Mexico

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Monterrey, Nuevo León, Mexico

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Oaxaca City, Mexico

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Querétaro, Mexico

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Querétaro, Mexico

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Cluj-Napoca, Cluj, Romania

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Oradea, Jud Bihor, Romania

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Timișoara, Timiș County, Romania

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Râmnicu Vâlcea, Vâlcea County, Romania

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Bucharest, Romania

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Bucharest, Romania

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Singapore, Singapore

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Singapore, Singapore

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Bundang Gu, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Daejeon, Korea, South Korea

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Busan, South Korea

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Daegu, South Korea

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Gwangju, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Santiago Compostela, A Coruna, Spain

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Barcelona, Catalonia, Spain

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El Palmar, Murcia, Spain

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Pamplona, Navarre, Spain

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Vigo, Pontevedra, Spain

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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

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Valencia, Valencia, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Songkhla, Hat Yai, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Bradford, West Yorkshire, United Kingdom

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London, United Kingdom

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Hanoi, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam

Clinical Research Directory

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (188)