Systemic Lupus Erythematosus (SLE) Clinical Trials

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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

Status: Recruiting
Location: See all (112) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable first-line SLE therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented diagnosis of systemic lupus erythematosus (SLE) within 2 years of signing the informed consent according to the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria 2019

• Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer greater than or equal to (\>=) 1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test from 2 independent time points

• 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) score 1 to 4 and prednisone or equivalent dose \>=10 milligram per day (mg/day)

• The Systematic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) = 0 at Screening

• Male and/or female; a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

• Not a Woman of childbearing potential (WOCBP) OR

• Is a WOCBP and using a contraceptive method that is highly effective

• Capable of giving signed informed consent

Locations
United States
Alabama
GSK Investigational Site
RECRUITING
Anniston
Arizona
GSK Investigational Site
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Flagstaff
GSK Investigational Site
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Mesa
GSK Investigational Site
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Tucson
California
GSK Investigational Site
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Covina
GSK Investigational Site
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Fontana
GSK Investigational Site
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Fullerton
GSK Investigational Site
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Long Beach
GSK Investigational Site
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Los Angeles
GSK Investigational Site
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Mission Hills
GSK Investigational Site
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San Diego
GSK Investigational Site
RECRUITING
Temecula
GSK Investigational Site
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Tujunga
GSK Investigational Site
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Van Nuys
GSK Investigational Site
RECRUITING
Van Nuys
GSK Investigational Site
RECRUITING
Whittier
Florida
GSK Investigational Site
RECRUITING
Aventura
GSK Investigational Site
RECRUITING
Clearwater
GSK Investigational Site
WITHDRAWN
Miami
GSK Investigational Site
RECRUITING
Tamarac
GSK Investigational Site
RECRUITING
Tampa
Georgia
GSK Investigational Site
RECRUITING
Atlanta
GSK Investigational Site
WITHDRAWN
Sugar Hill
Illinois
GSK Investigational Site
RECRUITING
Morton Grove
GSK Investigational Site
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Rockford
Louisiana
GSK Investigational Site
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Baton Rouge
GSK Investigational Site
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New Orleans
GSK Investigational Site
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Shreveport
Michigan
GSK Investigational Site
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Detroit
GSK Investigational Site
COMPLETED
Lansing
North Carolina
GSK Investigational Site
RECRUITING
Charlotte
GSK Investigational Site
RECRUITING
Winston-salem
New Jersey
GSK Investigational Site
RECRUITING
Sparta
New York
GSK Investigational Site
RECRUITING
Brooklyn
Pennsylvania
GSK Investigational Site
COMPLETED
Duncansville
GSK Investigational Site
RECRUITING
Philadelphia
Texas
GSK Investigational Site
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Austin
GSK Investigational Site
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Baytown
GSK Investigational Site
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Colleyville
GSK Investigational Site
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Fort Worth
GSK Investigational Site
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Houston
GSK Investigational Site
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Katy
GSK Investigational Site
RECRUITING
Plano
GSK Investigational Site
WITHDRAWN
Waco
Virginia
GSK Investigational Site
RECRUITING
Danville
Wisconsin
GSK Investigational Site
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Glendale
Other Locations
Argentina
GSK Investigational Site
RECRUITING
Berazategui
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
Ciudad Autonoma Buenos Aires
GSK Investigational Site
RECRUITING
Ciudad Autonoma De Buenos Aire
GSK Investigational Site
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La Plata
GSK Investigational Site
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Mar Del Plata
GSK Investigational Site
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Quilmes
GSK Investigational Site
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San Miguel De Tucumán
GSK Investigational Site
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Santa Fe
Brazil
GSK Investigational Site
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Belo Horizonte
GSK Investigational Site
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Cuiabá
GSK Investigational Site
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Juiz De Fora
GSK Investigational Site
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Passo Fundo
GSK Investigational Site
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Porto Alegre
GSK Investigational Site
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Porto Alegre
GSK Investigational Site
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Porto Alegre
GSK Investigational Site
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Salvador
GSK Investigational Site
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São José Do Rio Preto
GSK Investigational Site
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São Paulo
GSK Investigational Site
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São Paulo
France
GSK Investigational Site
RECRUITING
Angers
GSK Investigational Site
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Lille
GSK Investigational Site
RECRUITING
Pessac
GSK Investigational Site
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Rennes
GSK Investigational Site
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Saint-priest-en-jarez
GSK Investigational Site
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Toulouse
Germany
GSK Investigational Site
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Herne
GSK Investigational Site
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Lübeck
GSK Investigational Site
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Mainz
GSK Investigational Site
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Meerbusch
Greece
GSK Investigational Site
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Athens
GSK Investigational Site
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Athens
GSK Investigational Site
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Heraklion
GSK Investigational Site
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Thessaloniki
Italy
GSK Investigational Site
RECRUITING
Brescia
GSK Investigational Site
RECRUITING
Ferrara
GSK Investigational Site
RECRUITING
Milan
GSK Investigational Site
RECRUITING
Pisa
GSK Investigational Site
RECRUITING
Reggio Emilia
GSK Investigational Site
RECRUITING
Rome
GSK Investigational Site
RECRUITING
Rozzano
Japan
GSK Investigational Site
RECRUITING
Fukuoka
GSK Investigational Site
RECRUITING
Kanagawa
GSK Investigational Site
RECRUITING
Miyagi
GSK Investigational Site
RECRUITING
Osaka
GSK Investigational Site
RECRUITING
Tokyo
Mexico
GSK Investigational Site
RECRUITING
Cuauhtémoc
GSK Investigational Site
RECRUITING
Df
GSK Investigational Site
RECRUITING
Guadalajara Jalisco
GSK Investigational Site
RECRUITING
León
GSK Investigational Site
RECRUITING
Mérida
GSK Investigational Site
RECRUITING
Mexico City
GSK Investigational Site
RECRUITING
Mexico City
GSK Investigational Site
RECRUITING
Monterrey Nuevo Leon
GSK Investigational Site
RECRUITING
San Luis Potosí City
GSK Investigational Site
RECRUITING
Torreón
Portugal
GSK Investigational Site
RECRUITING
Almada
Spain
GSK Investigational Site
RECRUITING
Barcelona
GSK Investigational Site
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Castellon
GSK Investigational Site
RECRUITING
Córdoba
GSK Investigational Site
RECRUITING
Murcia
GSK Investigational Site
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Seville
GSK Investigational Site
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Valladolid
GSK Investigational Site
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Vigopontevedra
GSK Investigational Site
RECRUITING
Villajoyosa
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2029-05-29
Participants
Target number of participants: 350
Treatments
Experimental: Belimumab (GSK1550188)
Participants will receive GSK1550188.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov