Phase
Condition
Musculoskeletal Diseases
Connective Tissue Diseases
Treatment
Placebo
Belimumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis,dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixedconnective tissue disease (MCTD) in accordance with internationally recognizedclassification criteria
Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extentof greater than or equal to (≥) 10% of the whole lung (WLILD)
Evidence of ILD progression in the previous 24 months
Must be currently receiving stable standard therapy to manage ILD and/or underlyingCTD, or to have failed or failed to tolerate first line standard therapy.
Participant is capable and willing to self-administer the study medication or has acaregiver who is capable and willing to administer the study medication throughoutthe study
A female participant is eligible to participate if she is not pregnant orbreastfeeding, and one of the following conditions applies:
Is a woman of nonchildbearing potential (WONCBP) OR
Is a Woman of childbearing potential (WOCBP) and using a contraceptive methodthat is highly effective, with a failure rate of less than (<)1%
Capable of giving signed informed consent
Exclusion
Exclusion Criteria:
Diagnosis of ILD other than CTD-ILD.
Primary diagnosis of Systemic Sclerosis (SSc).
Participants with rapidly progressive disease (absolute drop of 10% or more of FVCbetween screening and baseline visit and/or recent pulmonary hospitalisation).
FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted or requiring supplementaloxygen at screening
History or presence of diffuse alveolar haemorrhage (DAH) or other confoundingpulmonary disease, signs, or symptoms
Pulmonary arterial hypertension requiring therapy, as determined by the investigatorat, or prior to first day of dosing (Day 1)
Dependence on continuous oxygen supplementation
History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematologic, or neurological disorders capable ofsignificantly altering the absorption, metabolism, or elimination of drugs;constituting a risk when taking the study intervention or interfering with theinterpretation of data
Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7).
Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD)
Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onsetor deteriorating neurologic signs and symptoms
Have evidence of moderate to severe depression, defined as PHQ-9 score ≥10, orserious current suicide risk, or any history of suicidal behavior in the last 6months and/or any suicidal ideation in the last 2 months, or who in theinvestigator's judgment, poses a significant suicide risk
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cellor squamous epithelial carcinomas of the skin that have been resected with noevidence of metastatic disease for 3 years
Breast cancer within the past 10 years
Major surgery (including joint surgery) within 3 months prior to screening orplanned during the duration of the study
An active infection, or a history of infections
Study Design
Connect with a study center
GSK Investigational Site
Buenos Aires, 1023
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, C1128AAF
ArgentinaActive - Recruiting
GSK Investigational Site
Cordoba, X5000AAW
ArgentinaActive - Recruiting
GSK Investigational Site
Mendoza, 5500
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario, S2002
ArgentinaActive - Recruiting
GSK Investigational Site
San Miguel de TucumAn, T4000
ArgentinaSite Not Available
GSK Investigational Site
Santa Fe, 3000
ArgentinaActive - Recruiting
GSK Investigational Site
Murdoch, Western Australia 6163
AustraliaActive - Recruiting
GSK Investigational Site
Adelaide, 5000
AustraliaSite Not Available
GSK Investigational Site
Woodville, 5011
AustraliaSite Not Available
GSK Investigational Site
Bruxelles, 1200
BelgiumActive - Recruiting
GSK Investigational Site
LiEge, 4000
BelgiumSite Not Available
GSK Investigational Site
Namur, 5000
BelgiumSite Not Available
GSK Investigational Site
Barra Mansa, 27323240
BrazilSite Not Available
GSK Investigational Site
Juiz de Fora, 36010-570
BrazilSite Not Available
GSK Investigational Site
Porto Alegre, 90480000
BrazilSite Not Available
GSK Investigational Site
SAo Paulo, 04004-030
BrazilSite Not Available
GSK Investigational Site
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
GSK Investigational Site
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 05403-900
BrazilSite Not Available
GSK Investigational Site
Montreal, H3T 1E2
CanadaSite Not Available
GSK Investigational Site
Trois RiviEres, G9A 4P3
CanadaSite Not Available
GSK Investigational Site
Beijing, 100730
ChinaActive - Recruiting
GSK Investigational Site
Chengdu, 610072
ChinaActive - Recruiting
GSK Investigational Site
Guangzhou, 510630
ChinaActive - Recruiting
GSK Investigational Site
Hangzhou, 310052
ChinaSite Not Available
GSK Investigational Site
Mianyang,
ChinaActive - Recruiting
GSK Investigational Site
Nanjing, 210029
ChinaSite Not Available
GSK Investigational Site
Nanning, 530000
ChinaActive - Recruiting
GSK Investigational Site
Shanghai, 200040
ChinaActive - Recruiting
GSK Investigational Site
Shenyang, 110001
ChinaSite Not Available
GSK Investigational Site
Suzhou,
ChinaActive - Recruiting
GSK Investigational Site
Tianjin, 300052
ChinaSite Not Available
GSK Investigational Site
ZhuZhou, 412007
ChinaActive - Recruiting
GSK Investigational Site
Angers Cedex 9, 49933
FranceSite Not Available
GSK Investigational Site
Le Kremlin-BicEtre, 94275
FranceSite Not Available
GSK Investigational Site
Lille, 59037
FranceSite Not Available
GSK Investigational Site
Pessac cedex, 33604
FranceSite Not Available
GSK Investigational Site
Rouen Cedex, 76000
FranceSite Not Available
GSK Investigational Site
Toulouse cedex 9, 31059
FranceSite Not Available
GSK Investigational Site
Essen, 45293
GermanyActive - Recruiting
GSK Investigational Site
Mainz, 55131
GermanySite Not Available
GSK Investigational Site
Minden, 32429
GermanySite Not Available
GSK Investigational Site
Sendenhorst, 48324
GermanySite Not Available
GSK Investigational Site
Wuerzburg, 97080
GermanySite Not Available
GSK Investigational Site
Athens, 124 62
GreeceActive - Recruiting
GSK Investigational Site
Larissa, 41110
GreeceActive - Recruiting
GSK Investigational Site
Ancona,
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20132
ItalySite Not Available
GSK Investigational Site
Modena, 41124
ItalySite Not Available
GSK Investigational Site
Napoli, 80131
ItalyActive - Recruiting
GSK Investigational Site
Padova,
ItalySite Not Available
GSK Investigational Site
Pavia, 27100
ItalySite Not Available
GSK Investigational Site
Pisa, 56126
ItalySite Not Available
GSK Investigational Site
Roma,
ItalyActive - Recruiting
GSK Investigational Site
Udine, 33100
ItalySite Not Available
GSK Investigational Site
Verona, 37134
ItalySite Not Available
GSK Investigational Site
Aichi, 470-1192
JapanActive - Recruiting
GSK Investigational Site
Fukuoka, 812-8582
JapanActive - Recruiting
GSK Investigational Site
Hiroshima, 734-8551
JapanActive - Recruiting
GSK Investigational Site
Hokkaido, 060-8648
JapanActive - Recruiting
GSK Investigational Site
Kanagawa, 216-8511
JapanActive - Recruiting
GSK Investigational Site
Miyagi, 983-8512
JapanActive - Recruiting
GSK Investigational Site
Miyazaki, 889-1692
JapanActive - Recruiting
GSK Investigational Site
Saitama, 350-0495
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 113-8603
JapanActive - Recruiting
GSK Investigational Site
Tottori, 683-8504
JapanActive - Recruiting
GSK Investigational Site
Yamanashi, 409-3898
JapanActive - Recruiting
GSK Investigational Site
Bucheon Kyunggi-Do, 420-717
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 06591
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Suwon Kyunggi-do, 443-721
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Yongsan-Ku Seoul,
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Chihuahua, 31000
MexicoSite Not Available
GSK Investigational Site
Ciudad de Mexico, 03310
MexicoSite Not Available
GSK Investigational Site
DF, 14080
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44650
MexicoSite Not Available
GSK Investigational Site
Merida, CP 97070
MexicoSite Not Available
GSK Investigational Site
Mexico, 14080
MexicoSite Not Available
GSK Investigational Site
Monterrey, 64460
MexicoSite Not Available
GSK Investigational Site
Maastricht, 6229 HX
NetherlandsSite Not Available
GSK Investigational Site
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
GSK Investigational Site
Utrecht, 3584 CX
NetherlandsActive - Recruiting
GSK Investigational Site
Ciudad de Panama, 7099
PanamaSite Not Available
GSK Investigational Site
Panama, 7002
PanamaSite Not Available
GSK Investigational Site
Panama City,
PanamaSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainActive - Recruiting
GSK Investigational Site
COrdoba, 14004
SpainSite Not Available
GSK Investigational Site
Granada, 18016
SpainSite Not Available
GSK Investigational Site
Madrid, 28007
SpainActive - Recruiting
GSK Investigational Site
Malaga, 29530
SpainSite Not Available
GSK Investigational Site
Pamplona, 31008
SpainActive - Recruiting
GSK Investigational Site
Santander, 39011
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Los Angeles, California 92868
United StatesSite Not Available
GSK Investigational Site
San Francisco, California 94143
United StatesSite Not Available
GSK Investigational Site
Upland, California 91786
United StatesSite Not Available
GSK Investigational Site
Gainesville, Florida 32608
United StatesSite Not Available
GSK Investigational Site
Naples, Florida 34102
United StatesActive - Recruiting
GSK Investigational Site
Bay Saint Louis, Mississippi 63110
United StatesSite Not Available
GSK Investigational Site
Saint Louis, Missouri 63110
United StatesSite Not Available
GSK Investigational Site
New York, New York 10032
United StatesSite Not Available
GSK Investigational Site
Potsdam, New York 13676
United StatesActive - Recruiting
GSK Investigational Site
Durham, North Carolina 27710
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77030
United StatesSite Not Available
GSK Investigational Site
Temple, Texas 76508
United StatesSite Not Available
GSK Investigational Site
Salt Lake City, Utah 84108
United StatesSite Not Available
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