Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis (SIRIUS-LN)

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).

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: ianalumab s.c. q4w; Drug: ianalumab s.c. q12w; Drug: placebo s.c.

Detailed Description

This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1426ABP
    • Novartis Investigative Site
  • Caba, Argentina, C1015ABO
    • Novartis Investigative Site
  • San Miguel de Tucumán, Argentina, 4000
    • Novartis Investigative Site
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1056ABI
      • Novartis Investigative Site
    • La Plata, Buenos Aires, Argentina, B1900AWT
      • Novartis Investigative Site
• Brazil
  • Salvador, Brazil, 40323-010
    • Novartis Investigative Site
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055 450
      • Novartis Investigative Site
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150 150
      • Novartis Investigative Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Novartis Investigative Site
    • Juiz de Fora, Minas Gerais, Brazil, 36010 570
      • Novartis Investigative Site
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-900
      • Novartis Investigative Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
      • Novartis Investigative Site
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Novartis Investigative Site
  • São Paulo
    • Santo André, São Paulo, Brazil, 09090-790
      • Novartis Investigative Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Novartis Investigative Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Novartis Investigative Site
  • Ontario
    • Etobicoke, Ontario, Canada, M9W 6V1
      • Novartis Investigative Site
    • London, Ontario, Canada, N6A 5W9
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Novartis Investigative Site
• Chile
  • Temuco, Chile, 4781151
    • Novartis Investigative Site
  • RM
    • Santiago, RM, Chile, 7500922
      • Novartis Investigative Site
• China
  • Beijing, China, 100034
    • Novartis Investigative Site
  • Chongqing, China, 400038
    • Novartis Investigative Site
  • Guangzhou, China, 510280
    • Novartis Investigative Site
  • Guangzhou, China, 510080
    • Novartis Investigative Site
  • Shanghai, China, 200080
    • Novartis Investigative Site
  • Shanghai, China, 200127
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510000
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510120
      • Novartis Investigative Site
    • Shantou, Guangdong, China, 515000
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518037
      • Novartis Investigative Site
  • Guangxi
    • Liuzhou, Guangxi, China, 545005
      • Novartis Investigative Site
  • Hainan
    • Haikou, Hainan, China, 570311
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Novartis Investigative Site
    • Wuhan, Hubei, China, 430022
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410008
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Novartis Investigative Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130041
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Novartis Investigative Site
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Novartis Investigative Site
    • Linyi, Shandong, China, 276000
      • Novartis Investigative Site
  • Shanxi
    • Xian, Shanxi, China, 710004
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Zhejiang
    • Ningbo, Zhejiang, China, 315016
      • Novartis Investigative Site
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050001
      • Novartis Investigative Site
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Novartis Investigative Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110111
      • Novartis Investigative Site
• Czechia
  • Olomouc, Czechia, 779 00
    • Novartis Investigative Site
  • Prague, Czechia, 128 00
    • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tallinn, Estonia, 10117
    • Novartis Investigative Site
• France
  • Besançon, France, 25030
    • Novartis Investigative Site
  • Bordeaux, France, 33076
    • Novartis Investigative Site
  • Grenoble, France, 38043
    • Novartis Investigative Site
  • Lyon, France, 69003
    • Novartis Investigative Site
  • Marseille, France, 13005
    • Novartis Investigative Site
  • Poitiers, France, 86021
    • Novartis Investigative Site
  • Toulouse, France, 31054
    • Novartis Investigative Site
  • Vandœuvre-lès-Nancy, France, 54511
    • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52074
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
  • Quetzaltenango, Guatemala, 9001
    • Novartis Investigative Site
• Hong Kong
  • Tuenmen, Hong Kong, 999077
    • Novartis Investigative Site
  • Kowloon
    • Kwun Tong, Kowloon, Hong Kong, 999077
      • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, H-1032
    • Novartis Investigative Site
  • Budapest, Hungary, H-1097
    • Novartis Investigative Site
  • Kaposvár, Hungary, 7400
    • Novartis Investigative Site
  • Hajdu Bihar Megye
    • Debrecen, Hajdu Bihar Megye, Hungary, 4032
      • Novartis Investigative Site
• India
  • Chandigarh, India, 160 012
    • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 079
      • Novartis Investigative Site
  • Telangana
    • Secunderabad, Telangana, India, 500003
      • Novartis Investigative Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226014
      • Novartis Investigative Site
• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Novartis Investigative Site
  • UD
    • Udine, UD, Italy, 33100
      • Novartis Investigative Site
• Lithuania
  • Vilnius, Lithuania, LT-08406
    • Novartis Investigative Site
  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
      • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Novartis Investigative Site
  • Sarawak
    • Sibu, Sarawak, Malaysia, 96000
      • Novartis Investigative Site
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia, 20400
      • Novartis Investigative Site
• Mexico
  • Oaxaca City, Mexico, 68020
    • Novartis Investigative Site
  • Querétaro, Mexico, 76070
    • Novartis Investigative Site
  • Guanajuato
    • León, Guanajuato, Mexico, 37160
      • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64440
      • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 022328
    • Novartis Investigative Site
  • Bucharest, Romania, 011172
    • Novartis Investigative Site
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Novartis Investigative Site
  • Jud Bihor
    • Oradea, Jud Bihor, Romania, 410619
      • Novartis Investigative Site
  • Timiș County
    • Timișoara, Timiș County, Romania, 300723
      • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 169608
    • Novartis Investigative Site
  • Singapore, Singapore, S308433
    • Novartis Investigative Site
• South Korea
  • Busan, South Korea, 49201
    • Novartis Investigative Site
  • Gwangju, South Korea, 61469
    • Novartis Investigative Site
  • Seoul, South Korea, 05505
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Novartis Investigative Site
  • Seoul, South Korea, 04763
    • Novartis Investigative Site
  • Seoul, South Korea, 06591
    • Novartis Investigative Site
  • Gyeonggi-do
    • Bundang Gu, Gyeonggi-do, South Korea, 13620
      • Novartis Investigative Site
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08035
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Madrid, Spain, 280796
    • Novartis Investigative Site
  • A Coruna
    • Santiago Compostela, A Coruna, Spain, 15706
      • Novartis Investigative Site
  • Catalonia
    • Barcelona, Catalonia, Spain, 08003
      • Novartis Investigative Site
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Novartis Investigative Site
  • Valencia
    • Valencia, Valencia, Spain, 46017
      • Novartis Investigative Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 407219
    • Novartis Investigative Site
  • Taipei, Taiwan, 11217
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10330
    • Novartis Investigative Site
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Chiang Mai, Thailand, 50200
    • Novartis Investigative Site
  • Hat Yai
    • Songkhla, Hat Yai, Thailand, 90110
      • Novartis Investigative Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • La Palma, California, United States, 90623
      • Advanced Medical Research
    • Orange, California, United States, 92868
      • University of California Irvine
    • Sacramento, California, United States, 95817
      • School Of Medicine
    • San Diego, California, United States, 92037
      • University of California San Diego
    • San Diego, California, United States, 92111
      • Kaiser Permanente
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30342
      • Fides Clinical Research
    • Lawrenceville, Georgia, United States, 30044
      • Parris and Associates Rheumatology
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Accurate Clinical Research
    • New Orleans, Louisiana, United States, 70112
      • UMC New Orleans
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Univ of Nevada School of Med
  • New York
    • Clifton Park, New York, United States, 12065
      • NY Nephrology
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10028
      • Northwell Health
    • Orchard Park, New York, United States, 14127
      • Circuit Clinical
    • The Bronx, New York, United States, 10468
      • James J Peters VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Univ of Pennsylvania Medical Center
  • Texas
    • Colleyville, Texas, United States, 76034
      • Precision Comprehensive Research
    • Dallas, Texas, United States, 75235
      • Univof Texas Southwestern Med Cntr
    • San Antonio, Texas, United States, 78229
      • Uni of Texas Health Science Center
  • Virginia
    • Fairfax, Virginia, United States, 22033
      • Northern Assoc of Northern VA
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Uni Wisconsin School Med Pub Health
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh City, Vietnam, 700000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - ianalumab s.c. q4w; ianalumab s.c. q4w in addition to standard of care (SoC)	Drug: ianalumab s.c. q4w; ianalumab s.c. q4w in addition to SoC; Other Names: VAY736
Experimental: Arm 2 - ianalumab s.c. q12w; ianalumab s.c. q12w in addition to SoC	Drug: ianalumab s.c. q12w; ianalumab s.c. q12w in addition to SoC; Other Names: VAY736
Placebo Comparator: Arm 3 - placebo s.c. q4w; Placebo s.c. q4w in addition to SoC	Drug: placebo s.c.; placebo s.c. q4w in addition to SoC; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and percentage of participants achieving stable Complete Renal Response (CRR)	The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR <0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy.	Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in British Isles Lupus Activity Group (BILAG) score	To demonstrate superiority of ianalumab, compared to placebo in BILAG-2004 at Week 72	Week 72
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score	To demonstrate superiority of ianalumab, compared to placebo, in FACIT-Fatigue at Week 72	Week 72
Ianalumab concentration in serum	To characterize the pharmacokinetics (PK) of ianalumab mean, median, minimum and maximum concentrations will be provided	Week 72
Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time	To evaluate immunogenicity of ianalumab	Week 72
Time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) <0.5 g/g or ≥50% reduction from baseline	To demonstrate superiority of ianalumab, compared to placebo, in time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) <0.5 g/g or ≥50% reduction from baseline up to Week 72	Week 72
Percentage of participants achieving stable Overall Renal Response (ORR), defined as achievement as either Complete Renal Response (CRR) or Partial Renal Response (PRR)	To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Overall Renal Response (ORR) at Week 48	Week 48
Incidence of stable Complete Renal Response (CRR) while maintaining daily corticosteroid dose ≤5 mg/day	To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Complete Renal Response (CRR) at Week 72 while maintaining daily corticosteroid dose ≤5 mg/day between Week 24 and Week 72	Week 72
Incidence of renal-related event or death	To demonstrate superiority of ianalumab, compared to placebo, in preventing renal-related event or death through Week 72	Week 72
Number of participants with treatment-emergent Adverse Events (AEs)	AEs are any untoward sign or symptom that occurs during the study treatment	Week 72

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): February 11, 2031

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: SLE; VAY736; B cell depletion; Systemic Lupus Erythematosus (SLE); Ianalumab; Kidney inflammation; Anti-BAFF-receptor
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; ianalumab
• Other Study ID Numbers: CVAY736K12301; 2020-005830-14 (EudraCT Number); 2023-508559-37-00 (Other Identifier: EU CTIS)

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