Actively Recruiting
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Led by GlaxoSmithKline · Updated on 2026-03-03
440
Participants Needed
131
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with active inflammatory connective tissue disease who have not achieved treatment goals or have worsening lung disease despite standard therapy
- Diagnosis of rheumatoid arthritis, systemic lupus erythematosus, idiopathic inflammatory myopathy (including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome, or mixed connective tissue disease using recognized criteria
- Diagnosis of inflammatory or fibrotic interstitial lung disease with at least 10% lung involvement on high-resolution CT
- Evidence of ongoing or worsening interstitial lung disease
- Currently on stable standard therapy for ILD or connective tissue disease, or have failed or cannot tolerate such therapy
- Able and willing to self-administer study medication or have a caregiver who can
- Female participants must not be pregnant or breastfeeding and either be of nonchildbearing potential or use highly effective contraception
- Able to provide signed informed consent
You will not qualify if you...
- Interstitial lung disease not related to connective tissue disease
- Primary diagnosis of systemic sclerosis
- Rapidly worsening disease with significant lung function drop or recent lung hospitalization
- Forced vital capacity 45% or less of predicted, or diffusion capacity 40% or less at screening
- History or presence of diffuse alveolar hemorrhage or other lung diseases that interfere with study
- Pulmonary arterial hypertension requiring treatment
- Dependence on continuous oxygen therapy
- Serious cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders impacting drug handling or study interpretation
- Obstructive lung disease confirmed by lung function tests
- Significant emphysema exceeding lung disease extent
- Confirmed progressive multifocal leukoencephalopathy or new/deteriorating neurological symptoms
- High suicide risk or recent suicidal behavior or ideation
- Cancer within the past 5 years except certain skin cancers, or breast cancer within 10 years
- Major surgery within 3 months before screening or planned during study
- Active or recent infections
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
Los Angeles, California, United States, 90033
Actively Recruiting
2
GSK Investigational Site
Los Angeles, California, United States, 90095
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3
GSK Investigational Site
Los Angeles, California, United States, 92868
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4
GSK Investigational Site
San Francisco, California, United States, 94143
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5
GSK Investigational Site
Upland, California, United States, 91786
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6
GSK Investigational Site
Gainesville, Florida, United States, 32608
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7
GSK Investigational Site
Naples, Florida, United States, 34102
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8
GSK Investigational Site
St Louis, Missouri, United States, 63110
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9
GSK Investigational Site
New York, New York, United States, 10029
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10
GSK Investigational Site
New York, New York, United States, 10032
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11
GSK Investigational Site
Potsdam, New York, United States, 13676
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12
GSK Investigational Site
Durham, North Carolina, United States, 27710
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13
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
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14
GSK Investigational Site
Houston, Texas, United States, 77030
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15
GSK Investigational Site
Temple, Texas, United States, 76508
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16
GSK Investigational Site
Salt Lake City, Utah, United States, 84108
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17
GSK Investigational Site
Buenos Aires, Argentina, 1023
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18
GSK Investigational Site
Buenos Aires, Argentina, C1128AAF
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19
GSK Investigational Site
Buenos Aires, Argentina, C1425AGC
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20
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
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21
GSK Investigational Site
Córdoba, Argentina, X5000AAW
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22
GSK Investigational Site
Mendoza, Argentina, 5500
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23
GSK Investigational Site
Rosario, Argentina, S2002
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24
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000
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25
GSK Investigational Site
Santa Fe, Argentina, 3000
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26
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
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27
GSK Investigational Site
Woodville, South Australia, Australia, 5011
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28
GSK Investigational Site
Spearwood, Western Australia, Australia, 6163
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29
GSK Investigational Site
Brussels, Belgium, 1090
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30
GSK Investigational Site
Brussels, Belgium, 1200
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31
GSK Investigational Site
Liège, Belgium, 4000
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32
GSK Investigational Site
Namur, Belgium
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33
GSK Investigational Site
Barra Mansa, Brazil, 27323240
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34
GSK Investigational Site
Juiz de Fora, Brazil, 36010-570
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35
GSK Investigational Site
Porto Alegre, Brazil, 90020-090
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36
GSK Investigational Site
Porto Alegre, Brazil, 90480000
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37
GSK Investigational Site
São José do Rio Preto, Brazil, 15090-000
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38
GSK Investigational Site
São Paulo, Brazil, 04004-030
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39
GSK Investigational Site
São Paulo, Brazil, 05403-900
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40
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
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41
GSK Investigational Site
Trois-Rivières, Quebec, Canada, G9A 4P3
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42
GSK Investigational Site
Beijing, China, 100020
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43
GSK Investigational Site
Beijing, China, 100730
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44
GSK Investigational Site
Chengdu, China, 610072
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45
GSK Investigational Site
Guangzhou, China, 510100
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46
GSK Investigational Site
Guangzhou, China, 510630
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47
GSK Investigational Site
Hangzhou, China, 310003
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48
GSK Investigational Site
Hangzhou, China, 310052
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49
GSK Investigational Site
Mianyang, China
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50
GSK Investigational Site
Nanjing, China, 210008
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51
GSK Investigational Site
Nanjing, China, 210029
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52
GSK Investigational Site
Nanning, China, 530000
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53
GSK Investigational Site
Shanghai, China, 200001
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54
GSK Investigational Site
Shanghai, China, 200040
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55
GSK Investigational Site
Shenyang, China, 110001
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56
GSK Investigational Site
Suzhou, China
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57
GSK Investigational Site
Tianjin, China, 300052
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58
GSK Investigational Site
Zhuzhou, China, 412007
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59
GSK Investigational Site
Angers, France, 49933
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60
GSK Investigational Site
Le Kremlin-Bicêtre, France, 94275
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61
GSK Investigational Site
Lille, France, 59037
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62
GSK Investigational Site
Pessac, France, 33604
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63
GSK Investigational Site
Rouen, France, 76000
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64
GSK Investigational Site
Toulouse, France, 31059
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65
GSK Investigational Site
Essen, Germany, 45293
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66
GSK Investigational Site
Mainz, Germany, 55131
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67
GSK Investigational Site
Minden, Germany, 32429
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68
GSK Investigational Site
Würzburg, Germany, 97080
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69
GSK Investigational Site
Athens, Greece, 106 76
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70
GSK Investigational Site
Athens, Greece, 124 62
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71
GSK Investigational Site
Athens, Greece, 12462
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72
GSK Investigational Site
Larissa, Greece, 41110
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73
GSK Investigational Site
Ancona, Italy
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74
GSK Investigational Site
Milan, Italy, 20132
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75
GSK Investigational Site
Milan, Italy
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76
GSK Investigational Site
Modena, Italy, 41124
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77
GSK Investigational Site
Naples, Italy, 80131
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78
GSK Investigational Site
Padova, Italy
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79
GSK Investigational Site
Pavia, Italy, 27100
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80
GSK Investigational Site
Pisa, Italy, 56126
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81
GSK Investigational Site
Roma, Italy, 00128
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82
GSK Investigational Site
Roma, Italy
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83
GSK Investigational Site
Udine, Italy, 33100
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84
GSK Investigational Site
Verona, Italy, 37134
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85
GSK Investigational Site
Aichi, Japan, 470-1192
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86
GSK Investigational Site
Fukuoka, Japan, 807-8556
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87
GSK Investigational Site
Fukuoka, Japan, 812-8582
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88
GSK Investigational Site
Hiroshima, Japan, 734-8551
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89
GSK Investigational Site
Hokkaido, Japan, 060-8648
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90
GSK Investigational Site
Kanagawa, Japan, 216-8511
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91
GSK Investigational Site
Miyagi, Japan, 983-8512
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92
GSK Investigational Site
Miyazaki, Japan, 889-1692
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93
GSK Investigational Site
Saitama, Japan, 350-0495
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94
GSK Investigational Site
Tokyo, Japan, 113-8519
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95
GSK Investigational Site
Tokyo, Japan, 113-8603
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96
GSK Investigational Site
Tokyo, Japan, 143-8541
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97
GSK Investigational Site
Tottori, Japan, 683-8504
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98
GSK Investigational Site
Yamanashi, Japan, 409-3898
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99
GSK Investigational Site
Chihuahua City, Mexico, 31000
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100
GSK Investigational Site
Guadalajara, Mexico, 44650
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101
GSK Investigational Site
Mexicali, Mexico, 21200
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102
GSK Investigational Site
Mexico City, Mexico, 03310
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103
GSK Investigational Site
Mérida, Mexico, CP 97070
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104
GSK Investigational Site
Monterrey, Mexico, 64460
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105
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
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106
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
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107
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
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108
GSK Investigational Site
Panama City, Panama, 07126
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109
GSK Investigational Site
Panama City, Panama, 7002
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110
GSK Investigational Site
Panama City, Panama, 7099
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111
GSK Investigational Site
Panama City, Panama
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112
GSK Investigational Site
Panama City, Panama
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113
GSK Investigational Site
Bucheon Kyunggi-Do, South Korea, 420-717
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114
GSK Investigational Site
Seoul, South Korea, 05505
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115
GSK Investigational Site
Seoul, South Korea, 06351
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116
GSK Investigational Site
Seoul, South Korea, 06591
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117
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 443-721
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118
GSK Investigational Site
Yongsan-Ku Seoul, South Korea
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119
GSK Investigational Site
Barcelona, Spain, 08025
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120
GSK Investigational Site
Barcelona, Spain, 08035
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121
GSK Investigational Site
Córdoba, Spain, 14004
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122
GSK Investigational Site
Granada, Spain, 18016
Withdrawn
123
GSK Investigational Site
Madrid, Spain, 28007
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124
GSK Investigational Site
Madrid, Spain, 28046
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125
GSK Investigational Site
Málaga, Spain, 29530
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126
GSK Investigational Site
Pamplona, Spain, 31008
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127
GSK Investigational Site
Santander, Spain, 39011
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128
GSK Investigational Site
Seville, Spain, 41013
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129
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
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130
GSK Investigational Site
Leicester, United Kingdom, LE3 9QP
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131
GSK Investigational Site
London, United Kingdom, SW3 6NP
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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