Actively Recruiting
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Led by Novartis Pharmaceuticals · Updated on 2026-03-13
550
Participants Needed
127
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
CONDITIONS
Official Title
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the extension study, including parental consent and child assent if under 18
- Participation and completion of treatment through Week 60 in either CVAY736F12301 or CVAY736F12302 core studies
- Investigator's judgment that continued study treatment will be clinically beneficial
You will not qualify if you...
- Use of prohibited therapies
- Active infections needing intravenous or intramuscular treatment posing risk for participation
- Plans to receive live vaccines during the study period
- Pregnant or nursing women
- Women of child-bearing potential not using effective contraception during and for 6 months after study treatment
- Sexually active males in the United States (and other countries if required) not agreeing to use barrier protection during intercourse 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: 127 locations
1
Pinnacle Research Group Llc
Anniston, Alabama, United States, 36207
Actively Recruiting
2
Providence Medical Center
Burbank, California, United States, 91505
Actively Recruiting
3
Advanced Medical Research
La Palma, California, United States, 90623
Actively Recruiting
4
Millennium Clinical Trials
Westlake Village, California, United States, 91361
Actively Recruiting
5
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Clinical Res Of W Florida
Clearwater, Florida, United States, 33765
Actively Recruiting
7
GNP Research
Cooper City, Florida, United States, 33024
Actively Recruiting
8
IRIS Research and Development
Plantation, Florida, United States, 33324
Actively Recruiting
9
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States, 30044
Actively Recruiting
10
Robert A Hozman MD SC
Skokie, Illinois, United States, 60076
Actively Recruiting
11
Willow Rheumatology Wellness
Willowbrook, Illinois, United States, 60527
Actively Recruiting
12
Accurate Clinical Research
Lake Charles, Louisiana, United States, 70601
Actively Recruiting
13
University Of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
15
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
16
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
17
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
18
Shelby Research LLC
Memphis, Tennessee, United States, 38119
Actively Recruiting
19
Novel Research LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
20
Accurate Clinical Research
League City, Texas, United States, 77573
Actively Recruiting
21
Epic Medical Research
Red Oak, Texas, United States, 75154
Actively Recruiting
22
Novartis Investigative Site
San Miguel, Buenos Aires, Argentina, B1663GKT
Actively Recruiting
23
Novartis Investigative Site
San Miguel, Tucumán Province, Argentina, T4000CBC
Actively Recruiting
24
Novartis Investigative Site
Caba, Argentina, C1015ABO
Actively Recruiting
25
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
26
Novartis Investigative Site
Maroochydore, Queensland, Australia, 4558
Actively Recruiting
27
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40150 150
Actively Recruiting
28
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
29
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 22211-230
Actively Recruiting
30
Novartis Investigative Site
Barretos, São Paulo, Brazil, 14784 400
Actively Recruiting
31
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01244-030
Actively Recruiting
32
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04038-002
Actively Recruiting
33
Novartis Investigative Site
Salvador, Brazil, 40323-010
Actively Recruiting
34
Novartis Investigative Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
35
Novartis Investigative Site
Sofia, Bulgaria, 1431
Actively Recruiting
36
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1L7
Active, Not Recruiting
37
Novartis Investigative Site
Rimouski, Quebec, Canada, G5L 5T1
Actively Recruiting
38
Novartis Investigative Site
Valdivia, Los Ríos Region, Chile, 5110683
Actively Recruiting
39
Novartis Investigative Site
Santiago, RM, Chile, 7500588
Actively Recruiting
40
Novartis Investigative Site
Santiago, Santiago Metropolitan, Chile, 7500710
Actively Recruiting
41
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
Actively Recruiting
42
Novartis Investigative Site
Shantou, Guangdong, China, 515000
Actively Recruiting
43
Novartis Investigative Site
Nanjing, Jiangsu, China, 210008
Actively Recruiting
44
Novartis Investigative Site
Suzhou, Jiangsu, China, 215004
Actively Recruiting
45
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
Active, Not Recruiting
46
Novartis Investigative Site
Pingxiang, Jiangxi, China, 337000
Actively Recruiting
47
Novartis Investigative Site
Changchun, Jilin, China, 130021
Actively Recruiting
48
Novartis Investigative Site
Linyi, Shandong, China, 276000
Actively Recruiting
49
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
50
Novartis Investigative Site
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
51
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
Actively Recruiting
52
Novartis Investigative Site
Beijing, China, 100069
Actively Recruiting
53
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
54
Novartis Investigative Site
Shanghai, China, 200127
Actively Recruiting
55
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050001
Active, Not Recruiting
56
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
57
Novartis Investigative Site
Chía, Cundinamarca, Colombia, 250001
Actively Recruiting
58
Novartis Investigative Site
Bucaramanga, Santander Department, Colombia, 680003
Actively Recruiting
59
Novartis Investigative Site
Bogotá, Colombia, 111211
Actively Recruiting
60
Novartis Investigative Site
Brno, Czechia, 638 00
Actively Recruiting
61
Novartis Investigative Site
Prague, Czechia, 128 00
Actively Recruiting
62
Novartis Investigative Site
Uherské Hradiště, Czechia, 686 01
Actively Recruiting
63
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
64
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
65
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
66
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
67
Novartis Investigative Site
Toulouse, France, 31059
Actively Recruiting
68
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
69
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
70
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Actively Recruiting
71
Novartis Investigative Site
Székesfehérvár, Fejér, Hungary, 8000
Actively Recruiting
72
Novartis Investigative Site
Gyula, Hungary, 5700
Actively Recruiting
73
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380006
Actively Recruiting
74
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380015
Actively Recruiting
75
Novartis Investigative Site
Kozhikode, Kerala, India, 673008
Actively Recruiting
76
Novartis Investigative Site
Nagpur, Maharashtra, India, 441108
Actively Recruiting
77
Novartis Investigative Site
Nashik, Maharashtra, India, 422101
Actively Recruiting
78
Novartis Investigative Site
Pune, Maharashtra, India, 411001
Actively Recruiting
79
Novartis Investigative Site
New Delhi, India, 110029
Actively Recruiting
80
Novartis Investigative Site
New Delhi, India, 110075
Actively Recruiting
81
Novartis Investigative Site
Haifa, Israel, 3109601
Active, Not Recruiting
82
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
83
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
84
Novartis Investigative Site
Torino, TO, Italy, 10128
Actively Recruiting
85
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4578510
Actively Recruiting
86
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
87
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
88
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1048560
Actively Recruiting
89
Novartis Investigative Site
Ipoh, Perak, Malaysia, 30450
Actively Recruiting
90
Novartis Investigative Site
León, Guanajuato, Mexico, 37160
Actively Recruiting
91
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44160
Actively Recruiting
92
Novartis Investigative Site
Mexico City, Mexico City, Mexico, 06700
Actively Recruiting
93
Novartis Investigative Site
Morelia, Michoacán, Mexico, 58000
Actively Recruiting
94
Novartis Investigative Site
Mérida, Yucatán, Mexico, 97070
Actively Recruiting
95
Novartis Investigative Site
México, Mexico, 07760
Actively Recruiting
96
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
Actively Recruiting
97
Novartis Investigative Site
Bydgoszcz, Poland, 85-065
Actively Recruiting
98
Novartis Investigative Site
Bydgoszcz, Poland, 85-168
Actively Recruiting
99
Novartis Investigative Site
Bytom, Poland, 41 902
Actively Recruiting
100
Novartis Investigative Site
Warsaw, Poland, 00-874
Actively Recruiting
101
Novartis Investigative Site
Warsaw, Poland, 04-141
Actively Recruiting
102
Novartis Investigative Site
Braga, Portugal, 4710243
Actively Recruiting
103
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania, 400006
Actively Recruiting
104
Novartis Investigative Site
Brasov, Romania, 500283
Actively Recruiting
105
Novartis Investigative Site
Bucharest, Romania, 011172
Actively Recruiting
106
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0002
Actively Recruiting
107
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7405
Actively Recruiting
108
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7500
Actively Recruiting
109
Novartis Investigative Site
Stellenbosch, Western Cape, South Africa, 7600
Actively Recruiting
110
Novartis Investigative Site
Gwangju Gwangyeoksi, Gwangju, South Korea, 61748
Actively Recruiting
111
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
112
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
113
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
114
Novartis Investigative Site
Badalona, Barcelona, Spain, 08916
Actively Recruiting
115
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
116
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
117
Novartis Investigative Site
San Sebastian Reyes, Madrid, Spain, 28702
Actively Recruiting
118
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
119
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
120
Novartis Investigative Site
Valencia, Spain, 46014
Actively Recruiting
121
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
122
Novartis Investigative Site
Taichung, Taiwan, 40447
Actively Recruiting
123
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
124
Novartis Investigative Site
Taipei, Taiwan, 11217
Actively Recruiting
125
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
126
Novartis Investigative Site
Bangkok, Thailand, 10400
Actively Recruiting
127
Novartis Investigative Site
Bangkok, Thailand, 10700
Actively 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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