Actively Recruiting
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Led by GlaxoSmithKline · Updated on 2026-01-12
300
Participants Needed
131
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older at the time of signing consent
- Documented diagnosis of systemic sclerosis (SSc) by 2013 classification criteria
- Diffuse cutaneous disease with thickened skin over at least one area proximal to elbows and/or knees
- Modified Rodnan Skin Score (mRSS) of 15 or higher on Day 1
- Evidence of interstitial lung disease on central HRCT scan
- Negative anticentromere antibody test at screening
- Evidence of active or progressive disease
- Area of uninvolved or mildly thickened skin suitable for subcutaneous injection
- Participant or caregiver capable and willing to administer study medication
- Female participants must not be pregnant or breastfeeding and must meet contraception requirements
- Able to provide signed informed consent
You will not qualify if you...
- Presence of systemic sclerosis-like illnesses other than diffuse cutaneous SSc
- Diagnosis of other rheumatic autoimmune diseases such as rheumatoid arthritis, lupus, polymyositis, dermatomyositis, vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease
- Forced Vital Capacity (FVC) less than 45% of predicted or Diffusing Capacity of the Lung for Carbon Monoxide (DLco) less than 40% or requiring supplemental oxygen
- Pulmonary arterial hypertension
- Scleroderma renal crisis within 6 months prior to dosing
- Significant disorders affecting drug metabolism or safety risk
- Obstructive pulmonary disease with FEV1/FVC ratio below 0.7
- Significant emphysema exceeding extent of interstitial lung disease on HRCT
- Previous or planned major organ or bone marrow transplant
- Recent treatment with biologic agents or monoclonal antibodies within 3 months or 5 half-lives
- Treatment with rituximab within 6 months prior to Day 1
- Recent treatment with non-biologic systemic immunosuppressives other than mycophenolate, methotrexate, or azathioprine within 3 months
- Treatment with cyclophosphamide within 6 months
- Use of anti-fibrotic agents within 4 weeks prior to Day 1
- Use of cytotoxic drugs such as chlorambucil or nitrogen mustard within 6 months
- Treatment with intramuscular or intravenous corticosteroids within 1 month prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 131 locations
1
GSK Investigational Site
Phoenix, Arizona, United States, 85027
Completed
2
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Actively Recruiting
4
GSK Investigational Site
Tucson, Arizona, United States, 85724
Actively Recruiting
5
GSK Investigational Site
Los Angeles, California, United States, 90095
Actively Recruiting
6
GSK Investigational Site
Los Angeles, California, United States, 90095
Actively Recruiting
7
GSK Investigational Site
Los Angeles, California, United States, 90301
Actively Recruiting
8
GSK Investigational Site
Upland, California, United States, 91786
Actively Recruiting
9
GSK Investigational Site
Aurora, Colorado, United States, 80033
Actively Recruiting
10
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
11
GSK Investigational Site
Jacksonville, Florida, United States, 32610
Actively Recruiting
12
GSK Investigational Site
Miami, Florida, United States, 33144
Actively Recruiting
13
GSK Investigational Site
Chicago, Illinois, United States, 60611
Actively Recruiting
14
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Actively Recruiting
15
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
16
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
17
GSK Investigational Site
New York, New York, United States, 10021
Actively Recruiting
18
GSK Investigational Site
New York, New York, United States, 11201
Actively Recruiting
19
GSK Investigational Site
Potsdam, New York, United States, 13676
Actively Recruiting
20
GSK Investigational Site
Cincinnati, Ohio, United States, 45206
Actively Recruiting
21
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
23
GSK Investigational Site
Denison, Texas, United States, 75020
Actively Recruiting
24
GSK Investigational Site
El Paso, Texas, United States, 79902
Actively Recruiting
25
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
26
GSK Investigational Site
Buenos Aires, Argentina
Actively Recruiting
27
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Actively Recruiting
28
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
Actively Recruiting
29
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Completed
30
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
31
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Actively Recruiting
32
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
33
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
34
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
35
GSK Investigational Site
Belo Horizonte, Brazil, 30150221
Actively Recruiting
36
GSK Investigational Site
Curitiba, Brazil, 80440-080
Completed
37
GSK Investigational Site
Juiz de Fora, Brazil, 36010-570
Actively Recruiting
38
GSK Investigational Site
Porto Alegre, Brazil, 90020-090
Actively Recruiting
39
GSK Investigational Site
Porto Alegre, Brazil
Actively Recruiting
40
GSK Investigational Site
Salvador, Brazil, 40.150-150
Actively Recruiting
41
GSK Investigational Site
São Paulo, Brazil, 01308-050
Actively Recruiting
42
GSK Investigational Site
São Paulo, Brazil, 04038-002
Actively Recruiting
43
GSK Investigational Site
Beijing, China, 100020
Actively Recruiting
44
GSK Investigational Site
Beijing, China, 100191
Actively Recruiting
45
GSK Investigational Site
Beijing, China, 100730
Actively Recruiting
46
GSK Investigational Site
Beijing, China, 100730
Actively Recruiting
47
GSK Investigational Site
Changchun, China, 130021
Actively Recruiting
48
GSK Investigational Site
Chengdu, China, 610041
Actively Recruiting
49
GSK Investigational Site
Chengdu, China, 610072
Actively Recruiting
50
GSK Investigational Site
Luzhou, China, 648000
Actively Recruiting
51
GSK Investigational Site
Mianyang, China
Actively Recruiting
52
GSK Investigational Site
Nanjing, China, 210008
Actively Recruiting
53
GSK Investigational Site
Nanjing, China, 210029
Actively Recruiting
54
GSK Investigational Site
Nanning, China, 530000
Actively Recruiting
55
GSK Investigational Site
Shanghai, China, 200001
Actively Recruiting
56
GSK Investigational Site
Shanghai, China, 200040
Actively Recruiting
57
GSK Investigational Site
Shenyang, China, 110001
Actively Recruiting
58
GSK Investigational Site
Xi'an, China, 710061
Actively Recruiting
59
GSK Investigational Site
Zhuzhou, China, 412007
Actively Recruiting
60
GSK Investigational Site
Aarhus, Denmark, 8200
Actively Recruiting
61
GSK Investigational Site
Odense C, Denmark, 5000
Withdrawn
62
GSK Investigational Site
Turku, Finland, 20520
Actively Recruiting
63
GSK Investigational Site
Bobigny, France, 93000
Actively Recruiting
64
GSK Investigational Site
Brest, France, 29609
Actively Recruiting
65
GSK Investigational Site
Paris, France, 75014
Actively Recruiting
66
GSK Investigational Site
Paris, France, 75014
Actively Recruiting
67
GSK Investigational Site
Paris, France, 75651
Actively Recruiting
68
GSK Investigational Site
Toulouse, France, 31059
Actively Recruiting
69
GSK Investigational Site
Cologne, Germany, 51149
Actively Recruiting
70
GSK Investigational Site
Düsseldorf, Germany, 40225
Actively Recruiting
71
GSK Investigational Site
Mainz, Germany, 55131
Actively Recruiting
72
GSK Investigational Site
Minden, Germany, 32429
Actively Recruiting
73
GSK Investigational Site
Tübingen, Germany, 72076
Actively Recruiting
74
GSK Investigational Site
Athens, Greece, 11527
Withdrawn
75
GSK Investigational Site
Athens, Greece, 12462
Actively Recruiting
76
GSK Investigational Site
Heraklion Crete, Greece, 71110
Actively Recruiting
77
GSK Investigational Site
Larissa, Greece, 41110
Actively Recruiting
78
GSK Investigational Site
Thessaloniki, Greece, 546 36
Actively Recruiting
79
GSK Investigational Site
Haifa, Israel, 3436212
Actively Recruiting
80
GSK Investigational Site
Holon, Israel, 58100
Withdrawn
81
GSK Investigational Site
Kfar Saba, Israel, 44281
Withdrawn
82
GSK Investigational Site
Poria – Neve Oved, Israel, 15208
Actively Recruiting
83
GSK Investigational Site
Ramat Gan, Israel, 52621
Actively Recruiting
84
GSK Investigational Site
Tel Aviv, Israel, 6423906
Actively Recruiting
85
GSK Investigational Site
Ancona, Italy, 60126
Actively Recruiting
86
GSK Investigational Site
Bari, Italy, 70124
Actively Recruiting
87
GSK Investigational Site
Cagliari, Italy, 09042
Actively Recruiting
88
GSK Investigational Site
Catania, Italy, 95123
Actively Recruiting
89
GSK Investigational Site
Ferrara, Italy, 44124
Actively Recruiting
90
GSK Investigational Site
Florence, Italy, 50134
Actively Recruiting
91
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
92
GSK Investigational Site
Modena, Italy, 41125
Actively Recruiting
93
GSK Investigational Site
Naples, Italy, 80131
Actively Recruiting
94
GSK Investigational Site
Orbassano to, Italy, 10043
Actively Recruiting
95
GSK Investigational Site
Padova, Italy, 35128
Actively Recruiting
96
GSK Investigational Site
Pavia, Italy, 27100
Actively Recruiting
97
GSK Investigational Site
Roma, Italy, 00161
Actively Recruiting
98
GSK Investigational Site
Roma, Italy, 00186
Actively Recruiting
99
GSK Investigational Site
Verona, Italy, 37134
Actively Recruiting
100
GSK Investigational Site
Gunma, Japan, 371-8511
Actively Recruiting
101
GSK Investigational Site
Hiroshima, Japan, 734-8551
Actively Recruiting
102
GSK Investigational Site
Hokkaido, Japan, 060-8543
Actively Recruiting
103
GSK Investigational Site
Hokkaido, Japan, 060-8648
Actively Recruiting
104
GSK Investigational Site
Kanagawa, Japan, 236-0051
Withdrawn
105
GSK Investigational Site
Miyagi, Japan, 980-8574
Actively Recruiting
106
GSK Investigational Site
Shizuoka, Japan, 431-3192
Actively Recruiting
107
GSK Investigational Site
Tokushima, Japan, 770-8503
Actively Recruiting
108
GSK Investigational Site
Tokyo, Japan, 113-8603
Actively Recruiting
109
GSK Investigational Site
Chihuahua City, Mexico, 31000
Actively Recruiting
110
GSK Investigational Site
Guadalajara, Mexico, 44650
Actively Recruiting
111
GSK Investigational Site
Mérida, Mexico, CP 97070
Actively Recruiting
112
GSK Investigational Site
Torreón, Mexico, 27000
Actively Recruiting
113
GSK Investigational Site
Seoul, South Korea, 04763
Actively Recruiting
114
GSK Investigational Site
Seoul, South Korea, 05505
Actively Recruiting
115
GSK Investigational Site
Seoul, South Korea, 06591
Actively Recruiting
116
GSK Investigational Site
Seoul, South Korea, 140 887
Actively Recruiting
117
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 16499
Actively Recruiting
118
GSK Investigational Site
Barcelona, Spain, 08025
Actively Recruiting
119
GSK Investigational Site
Barcelona, Spain, 08035
Actively Recruiting
120
GSK Investigational Site
Bilbao, Spain, 48013
Actively Recruiting
121
GSK Investigational Site
Granada, Spain, 18016
Actively Recruiting
122
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
123
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
124
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
125
GSK Investigational Site
Valencia, Spain, 46026
Actively Recruiting
126
GSK Investigational Site
VigoPontevedra, Spain, 36200
Actively Recruiting
127
GSK Investigational Site
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
128
GSK Investigational Site
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
129
GSK Investigational Site
London, United Kingdom, NW3 2QG
Actively Recruiting
130
GSK Investigational Site
Portsmouth, United Kingdom, SG1 4AB
Actively Recruiting
131
GSK Investigational Site
Wakefield, United Kingdom, WF1 4DG
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
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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