Actively Recruiting
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Led by Novartis Pharmaceuticals · Updated on 2026-03-11
200
Participants Needed
127
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
CONDITIONS
Official Title
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 70 years at screening
- Diagnosis of systemic sclerosis meeting 2013 ACR/EULAR criteria and classified as diffuse cutaneous systemic sclerosis
- Disease duration of 60 months or less from first non-Raynaud manifestation
- Modified Rodnan Skin Score (mRSS) between 15 and 45 at screening
- Active disease indicated by at least one: disease duration ≤18 months, increase in mRSS ≥3 units in past 6 months, involvement of new body areas with mRSS increase, elevated ESR or hsCRP, presence of interstitial lung disease with specific autoantibodies, or modified EUSTAR disease activity index ≥2.5
- Positive for at least one autoantibody: anti-topoisomerase I (ATA), anti-RNA polymerase III, or anti-nuclear antibody (ANA) with specific limits
- Women of childbearing potential must use highly effective contraception during and for 6 months after treatment
You will not qualify if you...
- Presence of rheumatic diseases other than diffuse cutaneous systemic sclerosis, including limited cutaneous or sine scleroderma
- Positive anti-centromere antibody without positive ATA or anti-RNAP3
- Previous improvement in mRSS greater than 10 units
- Pulmonary disease with FVC ≤50% or DLCO ≤40% predicted at screening
- WHO Functional Class 3 or higher pulmonary arterial hypertension or receiving intravenous therapy for PAH
- Treatment with cyclophosphamide within 12 weeks before baseline
- Prior B-cell depleting therapy other than ianalumab within 36 weeks or until B cell counts recover
- Use of biologic agents or investigational drugs within specified washout periods before baseline
- Use of anti-fibrotic agents within 4 weeks before baseline
- Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
- Women of childbearing potential not using highly effective contraception during and for 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 127 locations
1
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, United States, 85202
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
3
Hoag Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
4
Clinical Res Of W Florida
Clearwater, Florida, United States, 33765
Actively Recruiting
5
GNP Research
Cooper City, Florida, United States, 33024
Actively Recruiting
6
IRIS Research and Development
Plantation, Florida, United States, 33324
Actively Recruiting
7
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States, 34239
Actively Recruiting
8
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Actively Recruiting
9
UMC New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
10
Uni Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Wayne State University
Detroit, Michigan, United States, 48201
Actively Recruiting
12
Clinical Research Inst of MI
Saint Clair Shores, Michigan, United States, 48081
Actively Recruiting
13
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
14
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
15
Arthritis and Rheumatology Ins
Allen, Texas, United States, 75013
Actively Recruiting
16
Novel Research LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
17
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
18
Novartis Investigative Site
CABA, Buenos Aires, Argentina, 1280
Actively Recruiting
19
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1221ADC
Actively Recruiting
20
Novartis Investigative Site
Caba, Argentina, C1015ABO
Actively Recruiting
21
Novartis Investigative Site
Caba, Argentina, C1426
Actively Recruiting
22
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
23
Novartis Investigative Site
Graz, Austria, 8036
Actively Recruiting
24
Novartis Investigative Site
Leuven, Belgium, 3000
Actively Recruiting
25
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40150 150
Actively Recruiting
26
Novartis Investigative Site
Curitiba, Paraná, Brazil, 80030-110
Actively Recruiting
27
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
28
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo, Brazil, 15090 000
Actively Recruiting
29
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04038-002
Actively Recruiting
30
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
31
Novartis Investigative Site
Nanning, Guangxi, China, 530021
Actively Recruiting
32
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
Actively Recruiting
33
Novartis Investigative Site
Changchun, Jilin, China, 130021
Actively Recruiting
34
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
35
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
Actively Recruiting
36
Novartis Investigative Site
Beijing, China, 100191
Actively Recruiting
37
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
38
Novartis Investigative Site
Tianjin, China, 300052
Actively Recruiting
39
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
40
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110111
Actively Recruiting
41
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110221
Actively Recruiting
42
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760012
Actively Recruiting
43
Novartis Investigative Site
Bogotá, Colombia, 110231
Actively Recruiting
44
Novartis Investigative Site
Medellín, Colombia, 050034
Actively Recruiting
45
Novartis Investigative Site
Dijon, France, 21000
Actively Recruiting
46
Novartis Investigative Site
Le Mans, France, 72000
Actively Recruiting
47
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
48
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
49
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
50
Novartis Investigative Site
Rennes, France, 35033
Actively Recruiting
51
Novartis Investigative Site
Strasbourg, France, 67000
Actively Recruiting
52
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
53
Novartis Investigative Site
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
54
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
55
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
56
Novartis Investigative Site
Alexandroupoli, Greece, 681 00
Actively Recruiting
57
Novartis Investigative Site
Athens, Greece, 115 21
Actively Recruiting
58
Novartis Investigative Site
Athens, Greece, 115 27
Actively Recruiting
59
Novartis Investigative Site
Pécs, Baranya, Hungary, 7623
Actively Recruiting
60
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
61
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
62
Novartis Investigative Site
Kochi, Kerala, India, 682018
Actively Recruiting
63
Novartis Investigative Site
Mumbai, Maharashtra, India, 400013
Actively Recruiting
64
Novartis Investigative Site
Mumbai, Maharashtra, India, 400078
Actively Recruiting
65
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
66
Novartis Investigative Site
Jaipur, Rajasthan, India, 302004
Actively Recruiting
67
Novartis Investigative Site
New Delhi, India, 110029
Actively Recruiting
68
Novartis Investigative Site
Ancona, AN, Italy, 60126
Actively Recruiting
69
Novartis Investigative Site
Milan, MI, Italy, 20100
Actively Recruiting
70
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
71
Novartis Investigative Site
Modena, MO, Italy, 41124
Actively Recruiting
72
Novartis Investigative Site
Palermo, PA, Italy, 90127
Actively Recruiting
73
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
74
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
75
Novartis Investigative Site
Verona, VR, Italy, 37134
Actively Recruiting
76
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4578510
Actively Recruiting
77
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 8078556
Actively Recruiting
78
Novartis Investigative Site
Maebashi, Gunma, Japan, 371 8511
Actively Recruiting
79
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608543
Actively Recruiting
80
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
81
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan, 920 8641
Actively Recruiting
82
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
83
Novartis Investigative Site
Suita, Osaka, Japan, 5650871
Actively Recruiting
84
Novartis Investigative Site
Iruma-gun, Saitama, Japan, 3500495
Actively Recruiting
85
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
86
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1048560
Actively Recruiting
87
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan, 1628666
Actively Recruiting
88
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
89
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
90
Novartis Investigative Site
Hiroshima, Japan, 7348551
Actively Recruiting
91
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
92
Novartis Investigative Site
Toyama, Japan, 9300194
Actively Recruiting
93
Novartis Investigative Site
Cheras, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
94
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
95
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44650
Actively Recruiting
96
Novartis Investigative Site
Mexico City, Mexico City, Mexico, 06700
Actively Recruiting
97
Novartis Investigative Site
Mexico City, Mexico City, Mexico, 11850
Actively Recruiting
98
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
99
Novartis Investigative Site
Chihuahua City, Mexico, 31000
Actively Recruiting
100
Novartis Investigative Site
Bydgoszcz, Poland, 85-168
Actively Recruiting
101
Novartis Investigative Site
Warsaw, Poland, 00-874
Actively Recruiting
102
Novartis Investigative Site
Coimbra, Portugal, 3004-561
Actively Recruiting
103
Novartis Investigative Site
Lisbon, Portugal, 1649-035
Actively Recruiting
104
Novartis Investigative Site
Vila Nova de Gaia, Portugal, 4434 502
Actively Recruiting
105
Novartis Investigative Site
Seoul, Korea, South Korea, 03080
Active, Not Recruiting
106
Novartis Investigative Site
Busan, South Korea, 49241
Actively Recruiting
107
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
108
Novartis Investigative Site
Seoul, South Korea, 06273
Actively Recruiting
109
Novartis Investigative Site
Málaga, Andalusia, Spain, 29009
Actively Recruiting
110
Novartis Investigative Site
Valencia, Valencia, Spain, 46017
Actively Recruiting
111
Novartis Investigative Site
Barcelona, Spain, 08041
Actively Recruiting
112
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
113
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
114
Novartis Investigative Site
Changhua, Taiwan, 50006
Actively Recruiting
115
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
116
Novartis Investigative Site
Taichung, Taiwan, 40447
Actively Recruiting
117
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Actively Recruiting
118
Novartis Investigative Site
Khon Kaen, THA, Thailand, 40002
Actively Recruiting
119
Novartis Investigative Site
Bangkok, Thailand, 10400
Actively Recruiting
120
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
121
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
Actively Recruiting
122
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Actively Recruiting
123
Novartis Investigative Site
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Actively Recruiting
124
Novartis Investigative Site
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
125
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Actively Recruiting
126
Novartis Investigative Site
Ho Chi Minh City, VNM, Vietnam, 700000
Actively Recruiting
127
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
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
2
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