Actively Recruiting
A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus
Led by GlaxoSmithKline · Updated on 2026-06-03
350
Participants Needed
114
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus (SLE) who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab (GSK1550188) administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State (LLDAS) at week 52 and other measures such as the SLE Responder Index 4 (SRI4), flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.
CONDITIONS
Brief Title
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of systemic lupus erythematosus (SLE) within 2 years of signing informed consent according to EULAR/ACR 2019 criteria
- Positive autoantibody test results: ANA titer >= 1:80 and/or positive anti-dsDNA serum antibody from 2 independent tests
- Active SLE defined by Clinical SLEDAI-2K score > 4, or score 1 to 4 with prednisone dose >= 10 mg/day
- SLICC/ACR Damage Index (SDI) = 0 at screening
- Male or female; females must not be pregnant or breastfeeding and either not of childbearing potential or using highly effective contraception
- Capable of giving signed informed consent
You will not qualify if you...
- History of lymphoma, leukemia, or malignancy within past 5 years except certain skin cancers
- Significant unstable or uncontrolled acute or chronic diseases unrelated to SLE
- History of major organ or stem cell transplant
- Acute or chronic infections requiring ongoing suppressive therapy or recent serious infection
- Active or untreated latent tuberculosis
- Progressive multifocal leukoencephalopathy or severe active CNS lupus requiring recent intervention
- Active lupus nephritis requiring induction therapy
- Mental health risks including recent suicidal behavior or ideation
- Hypersensitivity to monoclonal antibodies or study drug components
- Recent live or live-attenuated vaccines
- Chronic oral steroid use for non-SLE diseases
- Use of high-dose immunosuppressants or certain biologics prior to screening
- History of primary immunodeficiency or severe neutropenia
- Abnormal liver function tests or significant liver disease
- Positive HIV, hepatitis B or C tests under specified conditions
- Current drug or alcohol dependence
- Recent participation in other investigational drug studies
- Unable to self-administer study drug or have reliable assistance at home
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.
Duration - Up to 52 weeks
Participants receive Belimumab administered subcutaneously to treat early Systemic Lupus Erythematosus (SLE).
Duration - Up to 104 weeks following treatment
Participants are monitored for efficacy and safety outcomes after treatment.
Trial Site Locations
Total: 114 locations
1
GSK Investigational Site
Anniston, Alabama, United States, 36207
Actively Recruiting
2
GSK Investigational Site
Flagstaff, Arizona, United States, 86001
Actively Recruiting
3
GSK Investigational Site
Mesa, Arizona, United States, 85210
Actively Recruiting
4
GSK Investigational Site
Tucson, Arizona, United States, 85748
Actively Recruiting
5
GSK Investigational Site
Covina, California, United States, 91722
Actively Recruiting
6
GSK Investigational Site
Fontana, California, United States, 92335
Actively Recruiting
7
GSK Investigational Site
Fullerton, California, United States, 92835
Actively Recruiting
8
GSK Investigational Site
Long Beach, California, United States, 90720
Actively Recruiting
9
GSK Investigational Site
Los Angeles, California, United States, 90211
Actively Recruiting
10
GSK Investigational Site
Mission Hills, California, United States, 91345
Actively Recruiting
11
GSK Investigational Site
San Diego, California, United States, 92128
Actively Recruiting
12
GSK Investigational Site
Temecula, California, United States, 92592
Actively Recruiting
13
GSK Investigational Site
Tujunga, California, United States, 91042
Actively Recruiting
14
GSK Investigational Site
Van Nuys, California, United States, 92307-2333
Actively Recruiting
15
GSK Investigational Site
Van Nuys, California, United States, 92586
Actively Recruiting
16
GSK Investigational Site
Whittier, California, United States, 90602
Actively Recruiting
17
GSK Investigational Site
Aventura, Florida, United States, 33180
Actively Recruiting
18
GSK Investigational Site
Clearwater, Florida, United States, 33765
Actively Recruiting
19
GSK Investigational Site
Miami, Florida, United States, 33126
Withdrawn
20
GSK Investigational Site
Tamarac, Florida, United States, 33321
Actively Recruiting
21
GSK Investigational Site
Tampa, Florida, United States, 33606
Actively Recruiting
22
GSK Investigational Site
Atlanta, Georgia, United States, 30152
Actively Recruiting
23
GSK Investigational Site
Sugar Hill, Georgia, United States, 30518
Withdrawn
24
GSK Investigational Site
Morton Grove, Illinois, United States, 60521
Actively Recruiting
25
GSK Investigational Site
Rockford, Illinois, United States, 60123
Actively Recruiting
26
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70836
Actively Recruiting
27
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Actively Recruiting
28
GSK Investigational Site
Shreveport, Louisiana, United States, 71115
Actively Recruiting
29
GSK Investigational Site
Detroit, Michigan, United States, 48202
Actively Recruiting
30
GSK Investigational Site
Lansing, Michigan, United States, 48910
Completed
31
GSK Investigational Site
Sparta, New Jersey, United States, 07871
Actively Recruiting
32
GSK Investigational Site
Brooklyn, New York, United States, 11201
Actively Recruiting
33
GSK Investigational Site
Charlotte, North Carolina, United States, 28202
Actively Recruiting
34
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
35
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Completed
36
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
37
GSK Investigational Site
Austin, Texas, United States, 78745
Actively Recruiting
38
GSK Investigational Site
Baytown, Texas, United States, 77521
Actively Recruiting
39
GSK Investigational Site
Colleyville, Texas, United States, 76034
Actively Recruiting
40
GSK Investigational Site
Fort Worth, Texas, United States, 76109
Actively Recruiting
41
GSK Investigational Site
Houston, Texas, United States, 77089
Actively Recruiting
42
GSK Investigational Site
Katy, Texas, United States, 77494
Actively Recruiting
43
GSK Investigational Site
Plano, Texas, United States, 75024
Actively Recruiting
44
GSK Investigational Site
Waco, Texas, United States, 76710
Withdrawn
45
GSK Investigational Site
Danville, Virginia, United States, 24541
Actively Recruiting
46
GSK Investigational Site
Glendale, Wisconsin, United States, 53217
Actively Recruiting
47
GSK Investigational Site
Berazategui, Argentina, 1884
Actively Recruiting
48
GSK Investigational Site
Buenos Aires, Argentina, C1121ABE
Actively Recruiting
49
GSK Investigational Site
Buenos Aires, Argentina, C1406AGA
Actively Recruiting
50
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Actively Recruiting
51
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1425
Actively Recruiting
52
GSK Investigational Site
La Plata, Argentina, B1900AX
Actively Recruiting
53
GSK Investigational Site
Mar del Plata, Argentina, 7600
Actively Recruiting
54
GSK Investigational Site
Quilmes, Argentina, B1878GEG
Actively Recruiting
55
GSK Investigational Site
San Miguel de Tucumán, Argentina, CP 4000
Actively Recruiting
56
GSK Investigational Site
Santa Fe, Argentina, S2000DSV
Actively Recruiting
57
GSK Investigational Site
Belo Horizonte, Brazil, 30150-221.
Actively Recruiting
58
GSK Investigational Site
Cuiabá, Brazil, 78020-840
Actively Recruiting
59
GSK Investigational Site
Juiz de Fora, Brazil, 36010-570
Actively Recruiting
60
GSK Investigational Site
Passo Fundo, Brazil, 99010-080
Actively Recruiting
61
GSK Investigational Site
Porto Alegre, Brazil, 90035-001
Actively Recruiting
62
GSK Investigational Site
Porto Alegre, Brazil, 90430-001
Actively Recruiting
63
GSK Investigational Site
Porto Alegre, Brazil, 90610-000
Actively Recruiting
64
GSK Investigational Site
Salvador, Brazil, 41820-020
Actively Recruiting
65
GSK Investigational Site
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
66
GSK Investigational Site
São Paulo, Brazil, 01323-001
Actively Recruiting
67
GSK Investigational Site
São Paulo, Brazil, 05403-000
Actively Recruiting
68
GSK Investigational Site
Angers, France, 49933
Actively Recruiting
69
GSK Investigational Site
Lille, France, 59800
Actively Recruiting
70
GSK Investigational Site
Pessac, France, 33604
Actively Recruiting
71
GSK Investigational Site
Rennes, France, 35200
Actively Recruiting
72
GSK Investigational Site
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
73
GSK Investigational Site
Toulouse, France, 31400
Actively Recruiting
74
GSK Investigational Site
Herne, Germany, 44649
Actively Recruiting
75
GSK Investigational Site
Lübeck, Germany, 23538
Actively Recruiting
76
GSK Investigational Site
Mainz, Germany, 55131
Actively Recruiting
77
GSK Investigational Site
Mainz, Germany, 55131
Actively Recruiting
78
GSK Investigational Site
Meerbusch, Germany, 40668
Actively Recruiting
79
GSK Investigational Site
Athens, Greece, 11 527
Actively Recruiting
80
GSK Investigational Site
Athens, Greece, 11527
Actively Recruiting
81
GSK Investigational Site
Athens, Greece, 12462
Actively Recruiting
82
GSK Investigational Site
Heraklion, Greece, 71500
Actively Recruiting
83
GSK Investigational Site
Thessaloniki, Greece, 54642
Actively Recruiting
84
GSK Investigational Site
Brescia, Italy, 25123
Actively Recruiting
85
GSK Investigational Site
Ferrara, Italy, 44124
Actively Recruiting
86
GSK Investigational Site
Milan, Italy, 20132
Actively Recruiting
87
GSK Investigational Site
Pisa, Italy, 56100
Actively Recruiting
88
GSK Investigational Site
Reggio Emilia, Italy, 42123
Actively Recruiting
89
GSK Investigational Site
Rome, Italy, 00168
Actively Recruiting
90
GSK Investigational Site
Rozzano, Italy, 20089
Actively Recruiting
91
GSK Investigational Site
Fukuoka, Japan, 807-8556
Actively Recruiting
92
GSK Investigational Site
Kanagawa, Japan, 252-0375
Actively Recruiting
93
GSK Investigational Site
Miyagi, Japan, 980-8574
Actively Recruiting
94
GSK Investigational Site
Osaka, Japan, 590-0197
Actively Recruiting
95
GSK Investigational Site
Tokyo, Japan, 104-8560
Actively Recruiting
96
GSK Investigational Site
Cuauhtémoc, Mexico City, Mexico, 06090
Actively Recruiting
97
GSK Investigational Site
DF, Mexico, 14000
Actively Recruiting
98
GSK Investigational Site
Guadalajara Jalisco, Mexico, 44950
Actively Recruiting
99
GSK Investigational Site
León, Mexico, 37000
Actively Recruiting
100
GSK Investigational Site
Mexico City, Mexico, 06700
Actively Recruiting
101
GSK Investigational Site
Mexico City, Mexico, 06726
Actively Recruiting
102
GSK Investigational Site
Mérida, Mexico, 97000
Actively Recruiting
103
GSK Investigational Site
Monterrey Nuevo LeOn, Mexico, 64000
Actively Recruiting
104
GSK Investigational Site
San Luis Potosí City, Mexico, 78200
Actively Recruiting
105
GSK Investigational Site
Torreón, Mexico, 27000
Actively Recruiting
106
GSK Investigational Site
Almada, Portugal, 2805-267
Actively Recruiting
107
GSK Investigational Site
Barcelona, Spain, 08003
Actively Recruiting
108
GSK Investigational Site
Castellon, Spain, 12004
Actively Recruiting
109
GSK Investigational Site
Córdoba, Spain, 14004
Actively Recruiting
110
GSK Investigational Site
Murcia, Spain, 30120
Actively Recruiting
111
GSK Investigational Site
Seville, Spain, 41014
Actively Recruiting
112
GSK Investigational Site
Valladolid, Spain, 47012
Actively Recruiting
113
GSK Investigational Site
VigoPontevedra, Spain, 36213
Actively Recruiting
114
GSK Investigational Site
Villajoyosa, Spain, 3570
Actively Recruiting
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
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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