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
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05126277 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Novartis Pharmaceuticals |
Principal Investigator Affiliation | Novartis Pharmaceuticals |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Brazil, Canada, Chile, China, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, India, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Romania, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States, Vietnam |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lupus Nephritis |
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).
Experimental: Arm 1 - ianalumab s.c. q4w
ianalumab s.c. q4w in addition to standard of care (SoC)
Experimental: Arm 2 - ianalumab s.c. q12w
ianalumab s.c. q12w in addition to SoC
Placebo Comparator: Arm 3 - placebo s.c. q4w
Placebo s.c. q4w in addition to SoC
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University Of Alabama
Birmingham, Alabama, 35294
Status
Withdrawn
Address
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Status
Recruiting
Address
University of California LA
Los Angeles, California, 90095
Status
Recruiting
Address
University of California Irvine
Orange, California, 92868
Status
Recruiting
Address
UC Davis School of Medicine
Sacramento, California, 95817
Status
Recruiting
Address
University of California San Diego
San Diego, California, 92037
Status
Recruiting
Address
Kaiser Permanente
San Diego, California, 92111
Status
Recruiting
Address
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Status
Recruiting
Address
University Of Miami
Miami, Florida, 33136
Status
Recruiting
Address
Emory University School of Medicine
Atlanta, Georgia, 30303
Status
Recruiting
Address
Fides Clinical Research
Atlanta, Georgia, 30342
Status
Recruiting
Address
Parris and Associates Rheumatology
Lawrenceville, Georgia, 30044
Status
Recruiting
Address
University of Kansas Hospital
Kansas City, Kansas, 66160
Status
Recruiting
Address
UMC New Orleans
New Orleans, Louisiana, 70112
Status
Recruiting
Address
Wayne State University
Detroit, Michigan, 48201
Status
Recruiting
Address
Univ of Nevada School of Med
Las Vegas, Nevada, 89102
Status
Recruiting
Address
Sahni Rheumatology and Therapy
West Long Branch, New Jersey, 07764
Status
Recruiting
Address
VA NM Healthcare System
Albuquerque, New Mexico, 87108
Status
Recruiting
Address
James J Peters VA Medical Center
Bronx, New York, 10468
Status
Recruiting
Address
NY Nephrology
Clifton Park, New York, 12065
Status
Recruiting
Address
Hospital for Special Surgery
New York, New York, 10021
Status
Recruiting
Address
Northwell Health
New York, New York, 10028
Status
Recruiting
Address
Circuit Clinical
Orchard Park, New York, 14127
Status
Withdrawn
Address
Brookview Hills Research Assoc
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
University Of Cincinnati
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Arthritis and Rheumatology Ins
Allen, Texas, 75013
Status
Recruiting
Address
Precision Comprehensive Research
Colleyville, Texas, 76034
Status
Recruiting
Address
Liberty Research Center
Dallas, Texas, 75230
Status
Recruiting
Address
Univof Texas Southwestern Med Cntr
Dallas, Texas, 75235
Status
Recruiting
Address
University of Texas Medical Branch
Galveston, Texas, 77555-0144
Status
Recruiting
Address
Uni of Texas Health Science Center
San Antonio, Texas, 78284
Status
Recruiting
Address
Baylor Scott and White Research
Temple, Texas, 76502
Status
Recruiting
Address
Northern Assoc of Northern VA
Fairfax, Virginia, 22033
Status
Recruiting
Address
Uni Wisconsin School Med Pub Health
Madison, Wisconsin, 53792
Status
Recruiting
Address
Novartis Investigative Site
Caba, Buenos Aires, C1056ABJ
Status
Recruiting
Address
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1015ABO
Status
Withdrawn
Address
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN
Status
Recruiting
Address
Novartis Investigative Site
La Plata, Buenos Aires, B1900AWT
Status
Recruiting
Address
Novartis Investigative Site
Ciudad Autonoma de Buenos Aire, , 1426
Status
Recruiting
Address
Novartis Investigative Site
Tucuman, , 4000
Status
Recruiting
Address
Novartis Investigative Site
Salvador, BA, 40150 150
Status
Recruiting
Address
Novartis Investigative Site
Vitoria, ES, 29055 450
Status
Withdrawn
Address
Novartis Investigative Site
Sao Luis, Maranhao, 65020-600
Status
Recruiting
Address
Novartis Investigative Site
Belo Horizonte, MG, 30150-221
Status
Recruiting
Address
Novartis Investigative Site
Juiz de Fora, MG, 36010 570
Status
Withdrawn
Address
Novartis Investigative Site
Curitiba, PR, 80440-020
Status
Recruiting
Address
Novartis Investigative Site
Pernambuco, Recife, 50740-900
Status
Recruiting
Address
Novartis Investigative Site
Porto Alegre, RS, 90020-090
Status
Recruiting
Address
Novartis Investigative Site
Porto Alegre, RS, 90035-003
Status
Recruiting
Address
Novartis Investigative Site
Santo Andre, SP, 09090-790
Status
Active, not recruiting
Address
Novartis Investigative Site
Salvador, , 40301-155
Status
Recruiting
Address
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6
Status
Recruiting
Address
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1L7
Status
Recruiting
Address
Novartis Investigative Site
Winnipeg, Manitoba, R3A 1R9
Status
Recruiting
Address
Novartis Investigative Site
Etobicoke, Ontario, M9W 6V1
Status
Recruiting
Address
Novartis Investigative Site
London, Ontario, N6A 5W9
Status
Recruiting
Address
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Status
Recruiting
Address
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Status
Recruiting
Address
Novartis Investigative Site
Sherbrooke, Quebec, J1G 2E8
Status
Recruiting
Address
Novartis Investigative Site
Santiago, RM, 7500922
Status
Recruiting
Address
Novartis Investigative Site
Temuco, , 4790084
Status
Recruiting
Address
Novartis Investigative Site
Hefei, Anhui, 230022
Status
Active, not recruiting
Address
Novartis Investigative Site
Guang Zhou, Guangdong, 510120
Status
Active, not recruiting
Address
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Status
Completed
Address
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Status
Active, not recruiting
Address
Novartis Investigative Site
Shantou, Guangdong, 515041
Status
Withdrawn
Address
Novartis Investigative Site
Shenzhen, Guangdong, 518020
Status
Active, not recruiting
Address
Novartis Investigative Site
Shenzhen, Guangdong, 518037
Status
Active, not recruiting
Address
Novartis Investigative Site
Liuzhou, Guangxi, 545005
Status
Active, not recruiting
Address
Novartis Investigative Site
Haikou, Hainan, 570311
Status
Active, not recruiting
Address
Novartis Investigative Site
Wuhan, Hubei, 430060
Status
Active, not recruiting
Address
Novartis Investigative Site
Changsha, Hunan, 410008
Status
Active, not recruiting
Address
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Status
Active, not recruiting
Address
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Status
Active, not recruiting
Address
Novartis Investigative Site
Changchun, Jilin, 130041
Status
Active, not recruiting
Address
Novartis Investigative Site
Shenyang, Liaoning, 110003
Status
Active, not recruiting
Address
Novartis Investigative Site
Binzhou, Shandong, 256603
Status
Recruiting
Address
Novartis Investigative Site
Linyi, Shandong, 276000
Status
Active, not recruiting
Address
Novartis Investigative Site
Xian, Shanxi, 710004
Status
Active, not recruiting
Address
Novartis Investigative Site
Chengdu, Sichuan, 610041
Status
Active, not recruiting
Address
Novartis Investigative Site
Beijing, , 100034
Status
Active, not recruiting
Address
Novartis Investigative Site
Chongqing, , 400038
Status
Completed
Address
Novartis Investigative Site
Guang Zhou, , 510080
Status
Active, not recruiting
Address
Novartis Investigative Site
Guangzhou, , 510280
Status
Active, not recruiting
Address
Novartis Investigative Site
Shanghai, , 200040
Status
Active, not recruiting
Address
Novartis Investigative Site
Shanghai, , 200080
Status
Completed
Address
Novartis Investigative Site
Shanghai, , 200127
Status
Active, not recruiting
Address
Novartis Investigative Site
Wuhan, , 430022
Status
Recruiting
Address
Novartis Investigative Site
Zhejiang, , 315016
Status
Recruiting
Address
Novartis Investigative Site
Medellin, Antioquia, 050001
Status
Recruiting
Address
Novartis Investigative Site
Bogota, Cundinamarca, 110111
Status
Recruiting
Address
Novartis Investigative Site
Barranquilla, , 080020
Status
Recruiting
Address
Novartis Investigative Site
Olomouc, , 779 00
Status
Recruiting
Address
Novartis Investigative Site
Praha 2, , 128 50
Status
Recruiting
Address
Novartis Investigative Site
Tallinn, , 10117
Status
Recruiting
Address
Novartis Investigative Site
Tallinn, , 10138
Status
Recruiting
Address
Novartis Investigative Site
Angers Cedex 9, , 49933
Status
Recruiting
Address
Novartis Investigative Site
Besancon Cedex, , 25030
Status
Recruiting
Address
Novartis Investigative Site
Bordeaux Cedex, , 33076
Status
Recruiting
Address
Novartis Investigative Site
Grenoble, , 38043
Status
Recruiting
Address
Novartis Investigative Site
Lyon, , 69003
Status
Recruiting
Address
Novartis Investigative Site
Marseille, , 13385
Status
Recruiting
Address
Novartis Investigative Site
Poitiers, , 86021
Status
Withdrawn
Address
Novartis Investigative Site
Regensburg, Bavaria, 93053
Status
Recruiting
Address
Novartis Investigative Site
Aachen, , 52074
Status
Recruiting
Address
Novartis Investigative Site
Bochum, , 44791
Status
Recruiting
Address
Novartis Investigative Site
Muenster, , 48149
Status
Recruiting
Address
Novartis Investigative Site
Guatemala City, , 01011
Status
Recruiting
Address
Novartis Investigative Site
Guatemala, , 01010
Status
Recruiting
Address
Novartis Investigative Site
Quetzaltenango, , 9001
Status
Recruiting
Address
Novartis Investigative Site
Kwun Tong, Kowloon,
Status
Recruiting
Address
Novartis Investigative Site
Tuen Mun, , 999077
Status
Recruiting
Address
Novartis Investigative Site
Budapest, , H-1032
Status
Recruiting
Address
Novartis Investigative Site
Budapest, , H-1097
Status
Recruiting
Address
Novartis Investigative Site
Debrecen, , 4032
Status
Recruiting
Address
Novartis Investigative Site
Kaposvar, , 7400
Status
Recruiting
Address
Novartis Investigative Site
Bangalore, Karnataka, 560 079
Status
Recruiting
Address
Novartis Investigative Site
Secunderabad, Telangana, 500003
Status
Recruiting
Address
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014
Status
Recruiting
Address
Novartis Investigative Site
Chandigarh, , 160 012
Status
Recruiting
Address
Novartis Investigative Site
Cagliari, CA, 09134
Status
Recruiting
Address
Novartis Investigative Site
Foggia, FG, 71122
Status
Recruiting
Address
Novartis Investigative Site
Firenze, FI, 50134
Status
Recruiting
Address
Novartis Investigative Site
Milano, MI, 20132
Status
Recruiting
Address
Novartis Investigative Site
Pavia, PV, 27100
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00168
Status
Recruiting
Address
Novartis Investigative Site
Torino, TO, 10154
Status
Recruiting
Address
Novartis Investigative Site
Udine, UD, 33100
Status
Withdrawn
Address
Novartis Investigative Site
Napoli, , 80131
Status
Recruiting
Address
Novartis Investigative Site
Bundang Gu, Gyeonggi Do, 13620
Status
Recruiting
Address
Novartis Investigative Site
Suwon si, Gyeonggi Do, 16499
Status
Withdrawn
Address
Novartis Investigative Site
Daejeon, Korea, 35015
Status
Recruiting
Address
Novartis Investigative Site
Busan, , 602 715
Status
Recruiting
Address
Novartis Investigative Site
Daegu, , 705 718
Status
Recruiting
Address
Novartis Investigative Site
Gwangju, , 61469
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 03722
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 04763
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 05030
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 05505
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 06591
Status
Recruiting
Address
Novartis Investigative Site
Kaunas, LTU, LT 50161
Status
Recruiting
Address
Novartis Investigative Site
Vilnius, , LT-08661
Status
Recruiting
Address
Novartis Investigative Site
Sibu, Sarawak, 96000
Status
Recruiting
Address
Novartis Investigative Site
Kuala Terengganu, Terengganu, 20400
Status
Recruiting
Address
Novartis Investigative Site
Kuala Lumpur, Wilayah Persekutuan, 50586
Status
Recruiting
Address
Novartis Investigative Site
Leon, Guanajuato, 37160
Status
Recruiting
Address
Novartis Investigative Site
Monterrey, Nuevo Leon, 64440
Status
Recruiting
Address
Novartis Investigative Site
Oaxaca, , 68020
Status
Withdrawn
Address
Novartis Investigative Site
Queretaro, , 76000
Status
Recruiting
Address
Novartis Investigative Site
Queretaro, , 76070
Status
Recruiting
Address
Novartis Investigative Site
Oradea, Jud Bihor, 410619
Status
Withdrawn
Address
Novartis Investigative Site
Ramnicu Valcea, Valcea, 240672
Status
Recruiting
Address
Novartis Investigative Site
Bucharest, , 022328
Status
Recruiting
Address
Novartis Investigative Site
Bucuresti, , 011172
Status
Recruiting
Address
Novartis Investigative Site
Cluj Napoca, , 400006
Status
Recruiting
Address
Novartis Investigative Site
Timisoara, , 300736
Status
Recruiting
Address
Novartis Investigative Site
Singapore, , 169608
Status
Recruiting
Address
Novartis Investigative Site
Singapore, , S308433
Status
Recruiting
Address
Novartis Investigative Site
Barcelona, Catalunya, 08003
Status
Recruiting
Address
Novartis Investigative Site
Barcelona, Catalunya, 08035
Status
Recruiting
Address
Novartis Investigative Site
Valencia, Comunidad Valenciana, 46017
Status
Recruiting
Address
Novartis Investigative Site
Santiago De Compostela, Galicia, 15706
Status
Withdrawn
Address
Novartis Investigative Site
El Palmar, Murcia, 30120
Status
Recruiting
Address
Novartis Investigative Site
Pamplona, Navarra, 31008
Status
Recruiting
Address
Novartis Investigative Site
Vigo, Pontevedra, 36200
Status
Recruiting
Address
Novartis Investigative Site
La Laguna, Santa Cruz De Tenerife, 38320
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 28040
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 28041
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 280796
Status
Recruiting
Address
Novartis Investigative Site
Kaohsiung, , 83301
Status
Recruiting
Address
Novartis Investigative Site
Taichung, , 40447
Status
Recruiting
Address
Novartis Investigative Site
Taichung, , 407219
Status
Recruiting
Address
Novartis Investigative Site
Taipei, , 11217
Status
Recruiting
Address
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Status
Recruiting
Address
Novartis Investigative Site
Bangkok, , 10330
Status
Recruiting
Address
Novartis Investigative Site
Bangkok, , 10400
Status
Recruiting
Address
Novartis Investigative Site
Bangkok, , 10700
Status
Recruiting
Address
Novartis Investigative Site
Chiang Mai, , 50200
Status
Recruiting
Address
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Status
Recruiting
Address
Novartis Investigative Site
London, , SE1 9RT
Status
Recruiting
Address
Novartis Investigative Site
Hanoi, , 100000
Status
Active, not recruiting
Address
Novartis Investigative Site
Ho Chi Minh, , 700000