Actively Recruiting
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
Led by Novartis Pharmaceuticals · Updated on 2026-03-18
462
Participants Needed
188
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at screening
- Weigh at least 35 kg
- Confirmed diagnosis of systemic lupus erythematosus (SLE) per EULAR/ACR criteria
- Positive anti-nuclear antibody (ANA) test with titer ≥ 1:80
- Active lupus nephritis with kidney biopsy within 6 months showing ISN/RPS class III, IV with or without class V, or pure class V membranous
- Urine protein to creatinine ratio (UPCR) ≥ 1.0 g/g on 24-hour urine collection
- Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2; if eGFR < 30, biopsy must show ≤ 50% glomeruli sclerosis
- Newly diagnosed or pre-treated lupus nephritis patients on or willing to start standard induction therapy with mycophenolic acid (MPA)
- Induction therapy including high-dose corticosteroids and MPA started before or on day of randomization
- Stable anti-malarial treatment recommended unless contraindicated
- Switch from azathioprine to MPA before randomization if applicable
- Received at least one dose of pulse methylprednisolone intravenous therapy within 60 days before randomization or started on oral prednisone if unable to receive pulse therapy
- Able to communicate and comply with study requirements
You will not qualify if you...
- Severe renal impairment defined as oliguria (<400 mL urine/24 hrs), end-stage renal disease requiring dialysis or transplantation
- Kidney biopsy showing >50% glomeruli sclerosis
- Use of other investigational drugs within 5 half-lives or 30 days before enrollment
- Prior use of ianalumab or recent B cell depleting therapies within 36 weeks
- Treatment with certain immunosuppressants or biologics within 12 weeks before randomization
- Discontinuation of imidazole derivatives before starting MPA
- More than 3000 mg cumulative intravenous pulse methylprednisolone within 12 weeks prior to randomization
- History of major organ or bone marrow transplant or planned transplantation
- Hemoglobin <8.0 g/dL or <7.0 g/dL if due to active hemolytic anemia
- Platelet count <25,000/µL or absolute neutrophil count <800/µL
- Active infections requiring intravenous or intramuscular treatment or recurrent significant infections
- Known intolerance or allergy to MPA, corticosteroids, or study drug components
- Receipt of live or attenuated vaccine within 4 weeks prior to randomization
- History of immunodeficiency including positive HIV test
- History of malignancy within past 5 years except certain skin or cervical cancers
- Medical, psychiatric, or surgical conditions that could jeopardize participation
- Chronic hepatitis B or C infection or positive hepatitis B surface antigen
- Active tuberculosis infection
- Pregnant or nursing women
- Women of child-bearing potential not using effective contraception during and for 6 months after treatment
- Sexually active men not agreeing to use barrier protection with women of child-bearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 188 locations
1
University Of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Advanced Medical Research
La Palma, California, United States, 90623
Actively Recruiting
3
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
Withdrawn
4
University of California LA
Los Angeles, California, United States, 90095
Actively Recruiting
5
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
6
School Of Medicine
Sacramento, California, United States, 95817
Actively Recruiting
7
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
8
Kaiser Permanente
San Diego, California, United States, 92111
Actively Recruiting
9
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
University Of Miami
Miami, Florida, United States, 33136
Actively Recruiting
11
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Actively Recruiting
12
Fides Clinical Research
Atlanta, Georgia, United States, 30342
Actively Recruiting
13
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States, 30044
Actively Recruiting
14
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Withdrawn
15
Accurate Clinical Research
Lake Charles, Louisiana, United States, 70601
Actively Recruiting
16
UMC New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
17
Wayne State University
Detroit, Michigan, United States, 48201
Actively Recruiting
18
Univ of Nevada School of Med
Las Vegas, Nevada, United States, 89102
Actively Recruiting
19
Sahni Rheumatology and Therapy
West Long Branch, New Jersey, United States, 07764
Withdrawn
20
VA NM Healthcare System
Albuquerque, New Mexico, United States, 87108
Actively Recruiting
21
NY Nephrology
Clifton Park, New York, United States, 12065
Actively Recruiting
22
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
23
Northwell Health
New York, New York, United States, 10028
Actively Recruiting
24
Circuit Clinical
Orchard Park, New York, United States, 14127
Actively Recruiting
25
James J Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
26
Brookview Hills Research Assoc
Winston-Salem, North Carolina, United States, 27103
Withdrawn
27
University Of Cincinnati
Cincinnati, Ohio, United States, 45267
Active, Not Recruiting
28
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
29
Arthritis and Rheumatology Ins
Allen, Texas, United States, 75013
Actively Recruiting
30
Precision Comprehensive Research
Colleyville, Texas, United States, 76034
Active, Not Recruiting
31
Liberty Research Center
Dallas, Texas, United States, 75230
Actively Recruiting
32
Univof Texas Southwestern Med Cntr
Dallas, Texas, United States, 75235
Actively Recruiting
33
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0144
Withdrawn
34
Uni of Texas Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
35
Baylor Scott and White Research
Temple, Texas, United States, 76502
Actively Recruiting
36
Northern Assoc of Northern VA
Fairfax, Virginia, United States, 22033
Actively Recruiting
37
Uni Wisconsin School Med Pub Health
Madison, Wisconsin, United States, 53792
Actively Recruiting
38
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1056ABI
Actively Recruiting
39
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1119ACN
Withdrawn
40
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1900AWT
Actively Recruiting
41
Novartis Investigative Site
Caba, Argentina, C1015ABO
Actively Recruiting
42
Novartis Investigative Site
CABA, Argentina, C1426ABP
Actively Recruiting
43
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
44
Novartis Investigative Site
Vitória, Espírito Santo, Brazil, 29055 450
Active, Not Recruiting
45
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40150 150
Actively Recruiting
46
Novartis Investigative Site
São Luís, Maranhão, Brazil, 65020-600
Withdrawn
47
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Active, Not Recruiting
48
Novartis Investigative Site
Juiz de Fora, Minas Gerais, Brazil, 36010 570
Active, Not Recruiting
49
Novartis Investigative Site
Curitiba, Paraná, Brazil, 80440-020
Withdrawn
50
Novartis Investigative Site
Recife, Pernambuco, Brazil, 50740-900
Active, Not Recruiting
51
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Active, Not Recruiting
52
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Active, Not Recruiting
53
Novartis Investigative Site
Santo André, São Paulo, Brazil, 09090-790
Active, Not Recruiting
54
Novartis Investigative Site
Salvador, Brazil, 40323-010
Active, Not Recruiting
55
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4Z6
Actively Recruiting
56
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1L7
Active, Not Recruiting
57
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R3A 1R9
Active, Not Recruiting
58
Novartis Investigative Site
Etobicoke, Ontario, Canada, M9W 6V1
Actively Recruiting
59
Novartis Investigative Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
60
Novartis Investigative Site
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
61
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
62
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
63
Novartis Investigative Site
Santiago, RM, Chile, 7500922
Active, Not Recruiting
64
Novartis Investigative Site
Temuco, Chile, 4781151
Active, Not Recruiting
65
Novartis Investigative Site
Hefei, Anhui, China, 230022
Withdrawn
66
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
Active, Not Recruiting
67
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
Active, Not Recruiting
68
Novartis Investigative Site
Guangzhou, Guangdong, China, 510120
Active, Not Recruiting
69
Novartis Investigative Site
Shantou, Guangdong, China, 515000
Active, Not Recruiting
70
Novartis Investigative Site
Shenzhen, Guangdong, China, 518020
Withdrawn
71
Novartis Investigative Site
Shenzhen, Guangdong, China, 518037
Active, Not Recruiting
72
Novartis Investigative Site
Liuzhou, Guangxi, China, 545005
Active, Not Recruiting
73
Novartis Investigative Site
Haikou, Hainan, China, 570311
Active, Not Recruiting
74
Novartis Investigative Site
Wuhan, Hubei, China, 430022
Active, Not Recruiting
75
Novartis Investigative Site
Wuhan, Hubei, China, 430060
Active, Not Recruiting
76
Novartis Investigative Site
Changsha, Hunan, China, 410008
Active, Not Recruiting
77
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Active, Not Recruiting
78
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
Active, Not Recruiting
79
Novartis Investigative Site
Changchun, Jilin, China, 130041
Active, Not Recruiting
80
Novartis Investigative Site
Shenyang, Liaoning, China, 110004
Active, Not Recruiting
81
Novartis Investigative Site
Binzhou, Shandong, China, 256603
Active, Not Recruiting
82
Novartis Investigative Site
Linyi, Shandong, China, 276000
Active, Not Recruiting
83
Novartis Investigative Site
Xian, Shanxi, China, 710004
Active, Not Recruiting
84
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Active, Not Recruiting
85
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
Active, Not Recruiting
86
Novartis Investigative Site
Beijing, China, 100034
Active, Not Recruiting
87
Novartis Investigative Site
Chongqing, China, 400038
Active, Not Recruiting
88
Novartis Investigative Site
Guangzhou, China, 510080
Active, Not Recruiting
89
Novartis Investigative Site
Guangzhou, China, 510280
Active, Not Recruiting
90
Novartis Investigative Site
Shanghai, China, 200040
Active, Not Recruiting
91
Novartis Investigative Site
Shanghai, China, 200080
Active, Not Recruiting
92
Novartis Investigative Site
Shanghai, China, 200127
Completed
93
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
94
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
95
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110111
Actively Recruiting
96
Novartis Investigative Site
Olomouc, Czechia, 779 00
Active, Not Recruiting
97
Novartis Investigative Site
Prague, Czechia, 128 00
Active, Not Recruiting
98
Novartis Investigative Site
Tallinn, Estonia, 10117
Actively Recruiting
99
Novartis Investigative Site
Tallinn, Estonia, 10138
Actively Recruiting
100
Novartis Investigative Site
Angers, France, 49933
Withdrawn
101
Novartis Investigative Site
Besançon, France, 25030
Active, Not Recruiting
102
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
103
Novartis Investigative Site
Grenoble, France, 38043
Actively Recruiting
104
Novartis Investigative Site
Lyon, France, 69003
Actively Recruiting
105
Novartis Investigative Site
Marseille, France, 13005
Actively Recruiting
106
Novartis Investigative Site
Poitiers, France, 86021
Actively Recruiting
107
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
108
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
109
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053
Withdrawn
110
Novartis Investigative Site
Aachen, Germany, 52074
Actively Recruiting
111
Novartis Investigative Site
Bochum, Germany, 44791
Actively Recruiting
112
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
113
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Actively Recruiting
114
Novartis Investigative Site
Guatemala City, Guatemala, 01011
Active, Not Recruiting
115
Novartis Investigative Site
Quetzaltenango, Guatemala, 9001
Active, Not Recruiting
116
Novartis Investigative Site
Kwun Tong, Kowloon, Hong Kong
Actively Recruiting
117
Novartis Investigative Site
Tuenmen, Hong Kong, 999077
Actively Recruiting
118
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
119
Novartis Investigative Site
Budapest, Hungary, H-1032
Actively Recruiting
120
Novartis Investigative Site
Budapest, Hungary, H-1097
Actively Recruiting
121
Novartis Investigative Site
Kaposvár, Hungary, 7400
Actively Recruiting
122
Novartis Investigative Site
Bangalore, Karnataka, India, 560 079
Active, Not Recruiting
123
Novartis Investigative Site
Secunderabad, Telangana, India, 500003
Actively Recruiting
124
Novartis Investigative Site
Secunderabad, Telangana, India, 500003
Active, Not Recruiting
125
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226014
Actively Recruiting
126
Novartis Investigative Site
Chandigarh, India, 160 012
Actively Recruiting
127
Novartis Investigative Site
Cagliari, CA, Italy, 09134
Withdrawn
128
Novartis Investigative Site
Foggia, FG, Italy, 71122
Actively Recruiting
129
Novartis Investigative Site
Florence, FI, Italy, 50134
Actively Recruiting
130
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
131
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
132
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
133
Novartis Investigative Site
Torino, TO, Italy, 10154
Actively Recruiting
134
Novartis Investigative Site
Udine, UD, Italy, 33100
Actively Recruiting
135
Novartis Investigative Site
Naples, Italy, 80131
Withdrawn
136
Novartis Investigative Site
Kaunas, LTU, Lithuania, LT 50161
Actively Recruiting
137
Novartis Investigative Site
Vilnius, Lithuania, LT-08406
Actively Recruiting
138
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Actively Recruiting
139
Novartis Investigative Site
Sibu, Sarawak, Malaysia, 96000
Actively Recruiting
140
Novartis Investigative Site
Kuala Terengganu, Terengganu, Malaysia, 20400
Actively Recruiting
141
Novartis Investigative Site
León, Guanajuato, Mexico, 37160
Actively Recruiting
142
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64440
Actively Recruiting
143
Novartis Investigative Site
Oaxaca City, Mexico, 68020
Actively Recruiting
144
Novartis Investigative Site
Querétaro, Mexico, 76000
Withdrawn
145
Novartis Investigative Site
Querétaro, Mexico, 76070
Actively Recruiting
146
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania, 400006
Actively Recruiting
147
Novartis Investigative Site
Oradea, Jud Bihor, Romania, 410619
Actively Recruiting
148
Novartis Investigative Site
Timișoara, Timiș County, Romania, 300723
Actively Recruiting
149
Novartis Investigative Site
Râmnicu Vâlcea, Vâlcea County, Romania, 240672
Withdrawn
150
Novartis Investigative Site
Bucharest, Romania, 011172
Actively Recruiting
151
Novartis Investigative Site
Bucharest, Romania, 022328
Actively Recruiting
152
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
153
Novartis Investigative Site
Singapore, Singapore, S308433
Actively Recruiting
154
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea, 13620
Actively Recruiting
155
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
156
Novartis Investigative Site
Daejeon, Korea, South Korea, 35015
Withdrawn
157
Novartis Investigative Site
Busan, South Korea, 49201
Actively Recruiting
158
Novartis Investigative Site
Daegu, South Korea, 705 718
Withdrawn
159
Novartis Investigative Site
Gwangju, South Korea, 61469
Actively Recruiting
160
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
161
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
162
Novartis Investigative Site
Seoul, South Korea, 05030
Withdrawn
163
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
164
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
165
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
166
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
167
Novartis Investigative Site
El Palmar, Murcia, Spain, 30120
Withdrawn
168
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
169
Novartis Investigative Site
Vigo, Pontevedra, Spain, 36214
Actively Recruiting
170
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
Actively Recruiting
171
Novartis Investigative Site
Valencia, Valencia, Spain, 46017
Actively Recruiting
172
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
173
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
174
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
175
Novartis Investigative Site
Madrid, Spain, 280796
Actively Recruiting
176
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
177
Novartis Investigative Site
Taichung, Taiwan, 40447
Actively Recruiting
178
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
179
Novartis Investigative Site
Taipei, Taiwan, 11217
Actively Recruiting
180
Novartis Investigative Site
Songkhla, Hat Yai, Thailand, 90110
Actively Recruiting
181
Novartis Investigative Site
Bangkok, Thailand, 10330
Actively Recruiting
182
Novartis Investigative Site
Bangkok, Thailand, 10400
Actively Recruiting
183
Novartis Investigative Site
Bangkok, Thailand, 10700
Actively Recruiting
184
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Actively Recruiting
185
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Actively Recruiting
186
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Actively Recruiting
187
Novartis Investigative Site
Hanoi, Vietnam, 100000
Active, Not Recruiting
188
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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