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

April 5, 2024 updated by: Novartis Pharmaceuticals

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

Recruiting

Conditions

Lupus Nephritis

Intervention / Treatment

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 (Estimated)

420

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Novartis Pharmaceuticals
Phone Number: 1-888-669-6682
Email: novartis.email@novartis.com

Study Contact Backup

Name: Novartis Pharmaceuticals
Phone Number: +41613241111

Study Locations

Argentina
- - Ciudad Autonoma de Buenos Aire, Argentina, 1426
    - Recruiting
    - Novartis Investigative Site
- Buenos Aires
  - Caba, Buenos Aires, Argentina, C1056ABJ
    - Recruiting
    - Novartis Investigative Site
  - Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1119ACN
    - Recruiting
    - Novartis Investigative Site
Brazil
- - Salvador, Brazil, 40301-155
    - Recruiting
    - Novartis Investigative Site
- BA
  - Salvador, BA, Brazil, 40150 150
    - Recruiting
    - Novartis Investigative Site
- ES
  - Vitoria, ES, Brazil, 29055 450
    - Recruiting
    - Novartis Investigative Site
- MG
  - Belo Horizonte, MG, Brazil, 30150-221
    - Recruiting
    - Novartis Investigative Site
  - Juiz de Fora, MG, Brazil, 36010 570
    - Recruiting
    - Novartis Investigative Site
- PR
  - Curitiba, PR, Brazil, 80440-020
    - Recruiting
    - Novartis Investigative Site
- RS
  - Porto Alegre, RS, Brazil, 90020-090
    - Recruiting
    - Novartis Investigative Site
  - Porto Alegre, RS, Brazil, 90035-003
    - Recruiting
    - Novartis Investigative Site
- Recife
  - Pernambuco, Recife, Brazil, 50740-900
    - Recruiting
    - Novartis Investigative Site
- SP
  - Santo Andre, SP, Brazil, 09090-790
    - Recruiting
    - Novartis Investigative Site
Canada
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - Novartis Investigative Site
- Quebec
  - Sherbrooke, Quebec, Canada, J1G 2E8
    - Recruiting
    - Novartis Investigative Site
Chile
- - Temuco, Chile, 4790084
    - Recruiting
    - Novartis Investigative Site
- RM
  - Santiago, RM, Chile, 7500922
    - Recruiting
    - Novartis Investigative Site
China
- - Beijing, China, 100034
    - Recruiting
    - Novartis Investigative Site
  - Chongqing, China, 400038
    - Recruiting
    - Novartis Investigative Site
  - Guang Zhou, China, 510080
    - Recruiting
    - Novartis Investigative Site
  - Guangzhou, China, 510280
    - Recruiting
    - Novartis Investigative Site
  - Shanghai, China, 200080
    - Recruiting
    - Novartis Investigative Site
  - Shanghai, China, 200040
    - Recruiting
    - Novartis Investigative Site
  - Shanghai, China, 200127
    - Recruiting
    - Novartis Investigative Site
  - Wuhan, China, 430022
    - Recruiting
    - Novartis Investigative Site
  - Zhejiang, China, 315016
    - Recruiting
    - Novartis Investigative Site
- Anhui
  - Hefei, Anhui, China, 230022
    - Recruiting
    - Novartis Investigative Site
- Guangdong
  - Guangzhou, Guangdong, China, 510000
    - Recruiting
    - Novartis Investigative Site
  - Guangzhou, Guangdong, China, 51000
    - Recruiting
    - Novartis Investigative Site
  - Shantou, Guangdong, China, 515041
    - Recruiting
    - Novartis Investigative Site
  - Shenzhen, Guangdong, China, 518037
    - Recruiting
    - Novartis Investigative Site
  - Shenzhen, Guangdong, China, 518020
    - Recruiting
    - Novartis Investigative Site
- Guangong
  - Zhanjing, Guangong, China, 524000
    - Recruiting
    - Novartis Investigative Site
- Guangxi
  - Liuzhou, Guangxi, China, 545005
    - Recruiting
    - Novartis Investigative Site
- Hainan
  - Haikou, Hainan, China, 570311
    - Recruiting
    - Novartis Investigative Site
- Hubei
  - Wuhan, Hubei, China, 430060
    - Recruiting
    - Novartis Investigative Site
- Hunan
  - Changsha, Hunan, China, 410008
    - Recruiting
    - Novartis Investigative Site
- Jiangsu
  - Nanjing, Jiangsu, China, 210029
    - Recruiting
    - Novartis Investigative Site
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - Novartis Investigative Site
- Jilin
  - Changchun, Jilin, China, 130041
    - Recruiting
    - Novartis Investigative Site
- Liaoning
  - Shenyang, Liaoning, China, 110003
    - Recruiting
    - Novartis Investigative Site
- Shandong
  - Binzhou, Shandong, China, 256603
    - Recruiting
    - Novartis Investigative Site
  - Linyi, Shandong, China, 276000
    - Recruiting
    - Novartis Investigative Site
- Shanxi
  - Xi'an, Shanxi, China, 710004
    - Recruiting
    - Novartis Investigative Site
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - Novartis Investigative Site
Colombia
- - Barranquilla, Colombia, 080020
    - Recruiting
    - Novartis Investigative Site
- Antioquia
  - Medellin, Antioquia, Colombia, 050001
    - Recruiting
    - Novartis Investigative Site
- Cundinamarca
  - Bogota, Cundinamarca, Colombia, 110111
    - Recruiting
    - Novartis Investigative Site
Czechia
- - Olomouc, Czechia, 779 00
    - Recruiting
    - Novartis Investigative Site
  - Prague 2, Czechia, 128 50
    - Recruiting
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 10138
    - Recruiting
    - Novartis Investigative Site
  - Tallinn, Estonia, 10117
    - Recruiting
    - Novartis Investigative Site
France
- - Angers Cedex 1, France, 49033
    - Recruiting
    - Novartis Investigative Site
  - Besancon Cedex, France, 25030
    - Recruiting
    - Novartis Investigative Site
  - Bordeaux, France, 33067
    - Recruiting
    - Novartis Investigative Site
  - Grenoble, France, 38043
    - Recruiting
    - Novartis Investigative Site
  - Lyon, France, 69437
    - Recruiting
    - Novartis Investigative Site
  - Marseille, France, 13385
    - Recruiting
    - Novartis Investigative Site
  - Poitiers, France, 86000
    - Recruiting
    - Novartis Investigative Site
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Novartis Investigative Site
  - Herne, Germany, 44625
    - Recruiting
    - Novartis Investigative Site
  - Muenster, Germany, 48149
    - Recruiting
    - Novartis Investigative Site
- Bavaria
  - Regensburg, Bavaria, Germany, 93053
    - Recruiting
    - Novartis Investigative Site
Guatemala
- - Guatemala, Guatemala, 01010
    - Recruiting
    - Novartis Investigative Site
  - Guatemala City, Guatemala, 01011
    - Recruiting
    - Novartis Investigative Site
  - Quetzaltenango, Guatemala, 9001
    - Recruiting
    - Novartis Investigative Site
Hong Kong
- - Tuen Mun, Hong Kong, 999077
    - Recruiting
    - Novartis Investigative Site
- Kowloon
  - Kwun Tong, Kowloon, Hong Kong
    - Recruiting
    - Novartis Investigative Site
Hungary
- - Budapest, Hungary, 1097
    - Recruiting
    - Novartis Investigative Site
  - Budapest, Hungary, H-1032
    - Recruiting
    - Novartis Investigative Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Novartis Investigative Site
  - Kaposvar, Hungary, 7400
    - Recruiting
    - Novartis Investigative Site
India
- - Chandigarh, India, 160 012
    - Recruiting
    - Novartis Investigative Site
- Karnataka
  - Bangalore, Karnataka, India, 560 079
    - Recruiting
    - Novartis Investigative Site
- Telangana
  - Secunderabad, Telangana, India, 500003
    - Recruiting
    - Novartis Investigative Site
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226014
    - Recruiting
    - Novartis Investigative Site
Italy
- - Napoli, Italy, 80131
    - Recruiting
    - Novartis Investigative Site
- FI
  - Firenze, FI, Italy, 50139
    - Recruiting
    - Novartis Investigative Site
- MI
  - Milano, MI, Italy, 20132
    - Recruiting
    - Novartis Investigative Site
- PV
  - Pavia, PV, Italy, 27100
    - Recruiting
    - Novartis Investigative Site
- RM
  - Roma, RM, Italy, 00168
    - Recruiting
    - Novartis Investigative Site
- TO
  - Torino, TO, Italy, 10154
    - Recruiting
    - Novartis Investigative Site
- UD
  - Udine, UD, Italy, 33100
    - Recruiting
    - Novartis Investigative Site
Korea, Republic of
- - Busan, Korea, Republic of, 602 715
    - Recruiting
    - Novartis Investigative Site
  - Daegu, Korea, Republic of, 705 718
    - Recruiting
    - Novartis Investigative Site
  - Gwangju, Korea, Republic of, 61469
    - Recruiting
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 04763
    - Recruiting
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 05030
    - Recruiting
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - Novartis Investigative Site
- Gyeonggi Do
  - Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
    - Recruiting
    - Novartis Investigative Site
  - Suwon si, Gyeonggi Do, Korea, Republic of, 16499
    - Recruiting
    - Novartis Investigative Site
- Korea
  - Daejeon, Korea, Korea, Republic of, 35015
    - Recruiting
    - Novartis Investigative Site
  - Seoul, Korea, Korea, Republic of, 05505
    - Recruiting
    - Novartis Investigative Site
Lithuania
- - Vilnius, Lithuania, LT-08661
    - Recruiting
    - Novartis Investigative Site
- LTU
  - Kaunas, LTU, Lithuania, LT 50161
    - Recruiting
    - Novartis Investigative Site
Malaysia
- - Kuala Lumpur, Malaysia, 50589
    - Recruiting
    - Novartis Investigative Site
- Sarawak
  - Sibu, Sarawak, Malaysia, 96000
    - Recruiting
    - Novartis Investigative Site
- Terengganu
  - Kuala Terengganu, Terengganu, Malaysia, 20400
    - Recruiting
    - Novartis Investigative Site
Mexico
- - Oaxaca, Mexico, 68020
    - Recruiting
    - Novartis Investigative Site
  - Queretaro, Mexico, 76070
    - Recruiting
    - Novartis Investigative Site
  - Queretaro, Mexico, 76000
    - Withdrawn
    - Novartis Investigative Site
- Guanajuato
  - Leon, Guanajuato, Mexico, 37160
    - Recruiting
    - Novartis Investigative Site
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64440
    - Recruiting
    - Novartis Investigative Site
Romania
- - Bucharest, Romania, 022328
    - Recruiting
    - Novartis Investigative Site
  - Cluj Napoca, Romania, 400006
    - Recruiting
    - Novartis Investigative Site
  - Timisoara, Romania, 300736
    - Recruiting
    - Novartis Investigative Site
- Jud. Bihor
  - Oradea, Jud. Bihor, Romania, 410619
    - Recruiting
    - Novartis Investigative Site
- Valcea
  - Ramnicu Valcea, Valcea, Romania, 240672
    - Recruiting
    - Novartis Investigative Site
Singapore
- - Singapore, Singapore, 169608
    - Recruiting
    - Novartis Investigative Site
  - Singapore, Singapore, 308433
    - Recruiting
    - Novartis Investigative Site
Spain
- - Madrid, Spain, 28041
    - Recruiting
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Recruiting
    - Novartis Investigative Site
- Catalunya
  - Barcelona, Catalunya, Spain, 08035
    - Recruiting
    - Novartis Investigative Site
  - Barcelona, Catalunya, Spain, 08003
    - Recruiting
    - Novartis Investigative Site
- Comunidad Valenciana
  - Valencia, Comunidad Valenciana, Spain, 46017
    - Recruiting
    - Novartis Investigative Site
- Galicia
  - Santiago De Compostela, Galicia, Spain, 15706
    - Recruiting
    - Novartis Investigative Site
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Recruiting
    - Novartis Investigative Site
- Pontevedra
  - Vigo, Pontevedra, Spain, 36200
    - Recruiting
    - Novartis Investigative Site
- Santa Cruz De Tenerife
  - La Laguna, Santa Cruz De Tenerife, Spain, 38320
    - Recruiting
    - Novartis Investigative Site
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Recruiting
    - Novartis Investigative Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Novartis Investigative Site
  - Taichung, Taiwan, 407
    - Recruiting
    - Novartis Investigative Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Novartis Investigative Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Novartis Investigative Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Novartis Investigative Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Novartis Investigative Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Novartis Investigative Site
- Songkla
  - Hat Yai, Songkla, Thailand, 90110
    - Recruiting
    - Novartis Investigative Site
United Kingdom
- - London, United Kingdom, SE1 9RT
    - Recruiting
    - Novartis Investigative Site
- West Yorkshire
  - Bradford, West Yorkshire, United Kingdom, BD9 6RJ
    - Recruiting
    - Novartis Investigative Site
United States
- California
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Wallace Rheumatic Study Center Research Department
    - Principal Investigator:
      
      Daniel Wallace
    - Contact:
      
      Carla Martinez
      
      Email: carla@walleemed.com
  - Orange, California, United States, 92868
    - Recruiting
    - University of California Irvine Research Department
    - Principal Investigator:
      
      Sheetal Desai
    - Contact:
      
      Ahmad Walid Roshan
      
      Email: ahmadwar@hs.uci.edu
  - San Diego, California, United States, 92111
    - Recruiting
    - Kaiser Permanente Dpt of Research and Evaluation
    - Principal Investigator:
      
      Hui Xue
    - Contact:
      
      Sinai Farah
      
      Phone Number: 858-401-7205
      
      Email: sfarah@wcgclinical.com
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Jacksonville .
    - Contact:
      
      Carolyne Stevens
      
      Phone Number: 904-953-2451
      
      Email: Thomas.Carolyne@mayo.edu
    - Principal Investigator:
      
      Nabeel Aslam
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Fides Clinical Research
    - Contact:
      
      Tu Tran
      
      Phone Number: 404-252-0256
      
      Email: ttran@fidesclinicalresearch.com
    - Principal Investigator:
      
      Elizabeth Nguyen
  - Lawrenceville, Georgia, United States, 30044
    - Recruiting
    - Parris and Associates Rheumatology
    - Contact:
      
      Phone Number: +17709621616#8334
    - Principal Investigator:
      
      Glenn Parris
- Kansas
  - Kansas City, Kansas, United States, 66160-7330
    - Recruiting
    - University of Kansas Medical Center CRAD001A2433
    - Contact:
      
      Phone Number: 913-588-0053
    - Principal Investigator:
      
      Kelly Liang
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - UMC New Orleans Nephrologist
    - Contact:
      
      Khahtahvah Joseph
      
      Email: Khahtahvah.joseph@lcmchealth.org
    - Principal Investigator:
      
      Stephen Lindsey
- Michigan
  - Detroit, Michigan, United States, 48201
    - Recruiting
    - Wayne State University
    - Principal Investigator:
      
      Yahya Osman
    - Contact:
      
      Danial Rashid
      
      Phone Number: 313-745-7371
      
      Email: drashid@med.wayne.edu
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Recruiting
    - VA NM Healthcare System
    - Contact:
      
      Kelli Ober
      
      Phone Number: 505-265-1711
      
      Email: kelli.ober@va.gov
    - Principal Investigator:
      
      Kavitha Ganta
- New York
  - Bronx, New York, United States, 10468
    - Recruiting
    - James J Peters VA Medical Center
    - Contact:
      
      Phone Number: +17185849000#6667
    - Principal Investigator:
      
      Kelly Steed
  - Clifton Park, New York, United States, 12065
    - Recruiting
    - NY Nephrology
    - Principal Investigator:
      
      Frank Cortazar
    - Contact:
      
      Phone Number: 518-579-0017
  - Orchard Park, New York, United States, 14127
    - Recruiting
    - Circuit Clinical Clinical Research
    - Contact:
      
      Sara Behrbom
      
      Email: sbehrbom@circuitclinical.com
    - Principal Investigator:
      
      Isha Gupta
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Brookview Hills Research Assoc Brookwood Hills Research Assoc
    - Principal Investigator:
      
      Nicholas McLean
    - Contact:
      
      Janice Rogers
      
      Phone Number: 336-768-2425
      
      Email: jrogers@brookviewhills.com
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - Recruiting
    - University Of Cincinnati .
    - Principal Investigator:
      
      Manish Anand
    - Contact:
      
      Phone Number: 513-559-3362
- Texas
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Liberty Research Center
    - Principal Investigator:
      
      Irfan Agha
    - Contact:
      
      Laurie Jones
      
      Phone Number: 972-274-5555
      
      Email: laurie.jones@usoncology.com
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Univof Texas Southwestern Med Cntr Dept Of Pediatrics
    - Principal Investigator:
      
      David Karp
  - Galveston, Texas, United States, 77555-0144
    - Recruiting
    - University of Texas Medical Branch .
    - Contact:
      
      Jana Lee
      
      Phone Number: 409-772-1062
      
      Email: jallee@utmb.edu
    - Principal Investigator:
      
      Tina Kochar
  - San Antonio, Texas, United States, 78284
    - Recruiting
    - Uni of Texas Health Science Center
    - Principal Investigator:
      
      Agustin Escalante
    - Contact:
      
      Phone Number: 210-617-5111
  - Temple, Texas, United States, 76502
    - Recruiting
    - Baylor Scott and White Research
    - Principal Investigator:
      
      Mohanram Narayanan
    - Contact:
      
      Michell Trevino
      
      Phone Number: 254-935-5838
      
      Email: michelle.trevino1@bswhealth.org
- Virginia
  - Fairfax, Virginia, United States, 22033
    - Recruiting
    - Northern Assoc of Northern VA
    - Contact:
      
      Phone Number: 703-953-0155
    - Principal Investigator:
      
      Gregory Wang
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Recruiting
    - Uni Wisconsin School Med Pub Health Clinical Research Office
    - Contact:
      
      Wayne Dorsey
      
      Email: wjdorsey@clinicaltrials.wisc.edu
    - Principal Investigator:
      
      Tripti Singh
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Novartis Investigative Site
  - Ho Chi Minh, Vietnam, 700000
    - Recruiting
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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) Time Frame: Week 72	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 Time Frame: Week 72	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 Time Frame: Week 72	To demonstrate superiority of ianalumab, compared to placebo, in FACIT-Fatigue at Week 72	Week 72
Ianalumab concentration in serum Time Frame: Week 72	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 Time Frame: Week 72	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 Time Frame: Week 72	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) Time Frame: Week 48	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 Time Frame: Week 72	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 Time Frame: Week 72	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) Time Frame: Week 72	AEs are any untoward sign or symptom that occurs during the study treatment	Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 15, 2030

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)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CVAY736K12301
2020-005830-14 (EudraCT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on ianalumab s.c. q4w

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