Phase
Condition
Cutaneous Lupus Erythematosus
Bone Diseases
Lupus
Treatment
Belimumab (GSK1550188)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented clinical diagnosis of SLE within 2 years of signing the informed consentaccording to the American College of Rheumatology (ACR) SLE classification criteria 2019
Have unequivocally positive autoantibody test results defined as an Anti-nuclearantibody (ANA) titer ≥1:80 and/or a positive anti-
Double stranded deoxyribonucleic acid (dsDNA) serum antibody test from 2 independent time points as follows:
Active SLE defined as:
Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score greater than (>) 4,OR
Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) ≤4 and prednisone orequivalent dose ≥10 milligram per day (mg/day)
The Systematic Lupus International Collaborating Clinics/American College ofRheumatology (SLICC/ACR) Damage Index (SDI) = 0 at Screening
Male and/or female; a female participant is eligible to participate if she is notpregnant, not breastfeeding, and at least one of the following conditions applies:
Not a Women of childbearing potential (WOCBP) OR
Is a WOCBP and using a contraceptive method that is highly effective
Capable of giving signed informed consent
Exclusion
Exclusion Criteria:
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.
Have clinical evidence of significant unstable or uncontrolled acute or chronicdiseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic,gastrointestinal (GI), hepatic, renal, neurological, psychiatric, malignancy, orinfectious diseases) and/or a planned surgical procedure, which, in the opinion ofthe principal investigator (PI), could confound the results of the clinical study orput the participant at undue risk.
Have an acute or chronic infection including requiring management as follows:
Currently on any suppressive therapy for a chronic infection such aspneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypicalmycobacteria.
A serious infection requiring treatment with intravenous or Intramuscular (IV/IM) antibiotics and/or hospitalization if the last dose of antibiotics orthe hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed.
Evidence of active or latent tuberculosis (TB) as documented by medical history andexamination, chest X-rays (posterior, anterior, and lateral), and TB testing: eithera positive tuberculin skin test (TST); defined as a skin induration ≥5millimeter (mm) at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or othervaccination history) or a positive (not indeterminate) interferon gamma releaseassay TB test.
Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onsetor deteriorating neurologic signs and symptoms.
Have severe active central nervous system (CNS) lupus (including seizures,psychosis, organic brain syndrome, Cerebrovascular accident (CVA), cerebritis, orCNS vasculitis) requiring therapeutic intervention within 60 days of Screening.
Lupus kidney disease defined by proteinuria >6 gram (g)/24 hour or equivalent usingspot urine protein to creatinine ratio, or serum creatinine >2.5 milligram perdecilitre (mg/dL) or have active LN requiring induction therapy within 35 days ofScreening.
Have evidence of serious suicide risk, defined as Patient Health Questionnaire (PHQ)-9 score ≥10, or any history of suicidal behavior in the last 6 months and/orany suicidal ideation in the last 2 months or who, in the investigator's opinion,pose a significant suicide risk.
Known to have titers of human anti-mouse antibody or history of hypersensitivityreactions when treated with diagnostic or therapeutic monoclonal antibodies
Live or live-attenuated vaccine(s) within 35 days prior to Screening or plans toreceive such vaccines during the Screening period or during the clinical study
Chronic oral steroid use for a non-SLE disorder at the Screening study visit (e.g.,for asthma). Inhaled steroid use will be allowed.
Treatment at or prior to Screening study visit:
• Treatment at Screening study visit with any of the following:
Azathioprine (AZA) >200 mg/day
Methotrexate (MTX) (any formulation) >25 mg/week
Mycophenolate mofetil (MMF) (PO)/MMF hydrochloride (IV) >2 g/day
Mycophenolate acid/sodium (PO) >1.44 g/day
Oral cyclophosphamide >2.5 mg/kg/day
Tacrolimus >0.2 mg/kg/day
Cyclosporine (PO) >2.5 mg/kg/day
• Treatment at any time prior to Screening with any of the following:
Second line use of conventional ISs or AMs
Commercially available Belimumab (BEL)
Anifrolumab
Rituximab or other B cell depleting therapies
Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab)
Other treatments with effects on the immune system (e.g., abatacept, interleukin-1receptor antagonist [anakinra], Janus kinase (JAK) inhibitors)
IV cyclophosphamide
IV immunoglobulin
Plasmapheresis
Intra-articular, IM, or IV corticosteroids within 6 weeks of Day 1
Daily use of >1 Nonsteroidal anti-inflammatory (NSAID) within 2 weeks prior to Day 1
History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G [IgG] <400 mg/dL) or Immunoglobulin A (IgA) deficiency (IgA <10 mg/dL)
Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/cubic millimetre (mm3) (<1.0 x109/L) based on the Common terminology criteriafor adverse events (CTCAE) v5.0 Alanine aminotransferase >2 x upper limit of normal (ULN)
Total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubinis fractionated and direct bilirubin <35 percent [%])
Have any other clinically significant abnormal laboratory value, that in the opinionof the investigator, is capable of significantly altering the absorption,metabolism, or elimination of the clinical study intervention; or constitutes a riskwhen taking the clinical study intervention or interferes with the interpretation ofthe clinical study data.
Positive Human immunodeficiency virus (HIV) antibody test
Presence of hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)at screening or within 3 months prior to first dose of study intervention.
Positive Hepatitis C antibody test result at screening or within 3 months prior tostarting study intervention. NOTE: Participants with positive Hepatitis C antibodydue to prior resolved disease can be enrolled, only if a confirmatory negativeHepatitis C Ribonucleic acid (RNA) test is obtained.
Positive Hepatitis C RNA test result at screening or within 3 months prior to firstdose of study intervention. NOTE: Test is optional and participants with negativeHepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
Sensitivity to the clinical study intervention, or components thereof, or monoclonalantibodies or drug or other allergy that, in the opinion of the investigator,contraindicates participation in the clinical study
Current drug or alcohol dependence, or a history of drug or alcohol abuse ordependence within 364 days prior to Day 1
Current enrolment or past participation in any other clinical study involving aninvestigational study intervention (including investigational vaccines) within 3months or 5 half-lives of the investigational drug (whichever is longer) beforeenrolment
Unable to administer clinical study intervention by subcutaneous (SC) auto-injectorand has no other reliable resource to administer the study intervention.
Study Design
Connect with a study center
GSK Investigational Site
Berazategui, Buenos Aires 1884
ArgentinaSite Not Available
GSK Investigational Site
La Plata, Buenos Aires 1900
ArgentinaSite Not Available
GSK Investigational Site
Mar del Plata, Buenos Aires 7600
ArgentinaSite Not Available
GSK Investigational Site
Quilmes, Buenos Aires B1878GEG
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA
ArgentinaSite Not Available
GSK Investigational Site
Rosario, Santa Fe S2000DSV
ArgentinaSite Not Available
GSK Investigational Site
San Miguel de Tucuman, Tucumán T4000AXL
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1121ABE
ArgentinaSite Not Available
GSK Investigational Site
Salvador, Bahia 41820-020
BrazilSite Not Available
GSK Investigational Site
Cuiaba, Mato Grosso 78020-840
BrazilSite Not Available
GSK Investigational Site
Belo Horizonte, Minas Gerais 30150-221.
BrazilSite Not Available
GSK Investigational Site
Juiz de Fora, Minas Gerais 36010-570
BrazilSite Not Available
GSK Investigational Site
Curitiba, Paraná 80440-080
BrazilSite Not Available
GSK Investigational Site
Passo Fundo, Rio Grande Do Sul 99010-080
BrazilSite Not Available
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul 90035-001
BrazilSite Not Available
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
GSK Investigational Site
São Paulo, 01327-001
BrazilSite Not Available
GSK Investigational Site
Pessac, Gironde 33604
FranceSite Not Available
GSK Investigational Site
Toulouse, Haute Garonne 31400
FranceSite Not Available
GSK Investigational Site
Rennes cedex 09, Ille Et Vilaine 35000
FranceSite Not Available
GSK Investigational Site
Lille, Nord 59800
FranceSite Not Available
GSK Investigational Site
Angers, 49000
FranceSite Not Available
GSK Investigational Site
Herne, Nordrhein-Westfalen 44649
GermanySite Not Available
GSK Investigational Site
Mainz, Rheinland-Pfalz 55101
GermanySite Not Available
GSK Investigational Site
Luebeck, Schleswig Holstein 23538
GermanySite Not Available
GSK Investigational Site
Athens, 12462
GreeceSite Not Available
GSK Investigational Site
Heraklion, 71500
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 54642
GreeceSite Not Available
GSK Investigational Site
Rome, Lazio 00168
ItalySite Not Available
GSK Investigational Site
Rozzano, Milano
ItalySite Not Available
GSK Investigational Site
Milano, 20132
ItalySite Not Available
GSK Investigational Site
Pisa, 56100
ItalySite Not Available
GSK Investigational Site
Kitakyushu-shi, Fukuoka-Ken 807-8556
JapanSite Not Available
GSK Investigational Site
Sendai-shi, Miyagi-Ken 980-8574
JapanSite Not Available
GSK Investigational Site
Osakasayama-shi, Osaka-Fu 589-8511
JapanSite Not Available
GSK Investigational Site
Kanagawa, 252-0375
JapanSite Not Available
GSK Investigational Site
Tokyo, 104-8560
JapanSite Not Available
GSK Investigational Site
Torreon, Coahuila 27000
MexicoSite Not Available
GSK Investigational Site
Ciudad de México, Distrito Federal 06700
MexicoSite Not Available
GSK Investigational Site
Leon, Guanajuato 37000
MexicoSite Not Available
GSK Investigational Site
León, Guanajuato 37000
MexicoSite Not Available
GSK Investigational Site
Guadalajara, Jalisco 44950
MexicoSite Not Available
GSK Investigational Site
Monterrey, Nuevo León 64000
MexicoSite Not Available
GSK Investigational Site
Merida, Yucatán 97000
MexicoSite Not Available
GSK Investigational Site
Mexico, 06726
MexicoSite Not Available
GSK Investigational Site
San Luis Potosí, 78200
MexicoSite Not Available
GSK Investigational Site
Almada, 2801-951
PortugalSite Not Available
GSK Investigational Site
Coimbra, 3000-075
PortugalSite Not Available
GSK Investigational Site
Lisboa, 1069-166
PortugalSite Not Available
GSK Investigational Site
Porto, 4099-001
PortugalSite Not Available
GSK Investigational Site
Valladolid, Cantabria 47012
SpainSite Not Available
GSK Investigational Site
Vigo, Pontevedra 36213
SpainSite Not Available
GSK Investigational Site
Barcelona, 08003
SpainSite Not Available
GSK Investigational Site
Córdoba, 14004
SpainSite Not Available
GSK Investigational Site
Sevilla, 41014
SpainSite Not Available
GSK Investigational Site
Vilajoyosa, 3570
SpainSite Not Available
GSK Investigational Site
Anniston, Alabama 36207
United StatesActive - Recruiting
GSK Investigational Site
Flagstaff, Arizona 86001
United StatesSite Not Available
GSK Investigational Site
Mesa, Arizona 85210
United StatesSite Not Available
GSK Investigational Site
Tucson, Arizona 85748
United StatesSite Not Available
GSK Investigational Site
Apple Valley, California 92307-2333
United StatesSite Not Available
GSK Investigational Site
Beverly Hills, California 90211
United StatesSite Not Available
GSK Investigational Site
Covina, California 91722
United StatesSite Not Available
GSK Investigational Site
Fontana, California 92335
United StatesSite Not Available
GSK Investigational Site
Fullerton, California 92835
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 90033
United StatesSite Not Available
GSK Investigational Site
Menifee, California 92586
United StatesSite Not Available
GSK Investigational Site
Mission Hills, California 91345
United StatesSite Not Available
GSK Investigational Site
Tujunga, California 91042
United StatesActive - Recruiting
GSK Investigational Site
Van Nuys, California 92586
United StatesActive - Recruiting
GSK Investigational Site
Whittier, California 90602
United StatesSite Not Available
GSK Investigational Site
Denver, Colorado 80230
United StatesSite Not Available
GSK Investigational Site
Aventura, Florida 33180
United StatesSite Not Available
GSK Investigational Site
Clearwater, Florida 33765
United StatesActive - Recruiting
GSK Investigational Site
Miami, Florida 33126
United StatesActive - Recruiting
GSK Investigational Site
Tamarac, Florida 33321
United StatesActive - Recruiting
GSK Investigational Site
Tampa, Florida 33606
United StatesActive - Recruiting
GSK Investigational Site
Atlanta, Georgia 30152
United StatesActive - Recruiting
GSK Investigational Site
Marietta, Georgia 30152
United StatesSite Not Available
GSK Investigational Site
Sugar Hill, Georgia 30518
United StatesActive - Recruiting
GSK Investigational Site
Chicago, Illinois 60612
United StatesSite Not Available
GSK Investigational Site
Elgin, Illinois 60123
United StatesSite Not Available
GSK Investigational Site
Hinsdale, Illinois 60521
United StatesSite Not Available
GSK Investigational Site
Morton Grove, Illinois 60521
United StatesActive - Recruiting
GSK Investigational Site
Baton Rouge, Louisiana 70836
United StatesSite Not Available
GSK Investigational Site
New Orleans, Louisiana 32204
United StatesSite Not Available
GSK Investigational Site
Shreveport, Louisiana 71115
United StatesSite Not Available
GSK Investigational Site
Detroit, Michigan 48202
United StatesSite Not Available
GSK Investigational Site
Lansing, Michigan 48910
United StatesActive - Recruiting
GSK Investigational Site
Sparta, New Jersey 07871
United StatesSite Not Available
GSK Investigational Site
Brooklyn, New York 11201
United StatesSite Not Available
GSK Investigational Site
Winston-Salem, North Carolina 27157
United StatesSite Not Available
GSK Investigational Site
Minot, North Dakota 58701
United StatesSite Not Available
GSK Investigational Site
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
GSK Investigational Site
Austin, Texas 78745
United StatesSite Not Available
GSK Investigational Site
Baytown, Texas 77521
United StatesActive - Recruiting
GSK Investigational Site
Colleyville, Texas 76034
United StatesActive - Recruiting
GSK Investigational Site
Fort Worth, Texas 76109
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77089
United StatesActive - Recruiting
GSK Investigational Site
Katy, Texas 77494
United StatesSite Not Available
GSK Investigational Site
Pearland, Texas 77584
United StatesSite Not Available
GSK Investigational Site
Plano, Texas 75024
United StatesSite Not Available
GSK Investigational Site
Waco, Texas 76710
United StatesSite Not Available
GSK Investigational Site
Danville, Virginia 24541
United StatesActive - Recruiting
GSK Investigational Site
Glendale, Wisconsin 53217
United StatesActive - Recruiting
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