Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease (ILD) linked to connective tissue diseases (CTDs) such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatment's impact on lung disease progression and patient well-being.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosis of rheumatoid arthritis, systemic lupus erythematosus, idiopathic inflammatory myopathy, Sjogren's syndrome, or mixed connective tissue disease
- Diagnosis of inflammatory and/or fibrotic interstitial lung disease affecting at least 10% of the lung on high resolution CT scan
- Active or worsening interstitial lung disease despite standard therapy
- Currently receiving stable standard therapy for lung disease or connective tissue disease, or have failed or not tolerated standard therapy
- Able and willing to self-administer study medication or have a caregiver who can
- Women must not be pregnant or breastfeeding, and if of childbearing potential, must use highly effective contraception
- Able to provide signed informed consent
You will not qualify if you...
- Interstitial lung disease not associated with connective tissue disease
- Primary diagnosis of systemic sclerosis
- Rapidly progressive disease with significant lung function drop or recent pulmonary hospitalization
- Forced vital capacity ≤ 45% predicted or diffusing capacity of lung for carbon monoxide ≤ 40% predicted
- History or presence of diffuse alveolar hemorrhage or other confounding lung diseases
- Pulmonary arterial hypertension requiring treatment
- Dependence on continuous oxygen therapy
- Significant other medical conditions affecting drug metabolism or safety
- Obstructive pulmonary disease with FEV1/FVC < 0.7
- Significant emphysema exceeding lung fibrosis extent
- Confirmed progressive multifocal leukoencephalopathy or worsening neurologic symptoms
- Significant suicide risk or recent suicidal behavior
- Recent or active cancers except certain skin cancers
- Major surgery within 3 months before screening or planned during the study
- Active infection or history of infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive belimumab or placebo in addition to their standard therapy to evaluate the efficacy and safety of the study drug.
Visits at baseline and Week 52
Duration - Up to 8 weeks after treatment
Participants are monitored for safety and adverse events after the treatment period ends.
Visits up to Week 60
Trial Site Locations
Total: 131 locations
1
GSK Investigational Site
Los Angeles, California, United States, 90033
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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
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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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