A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) (BE-EARLY)

June 1, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Berazategui, Argentina, 1884
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Pablo Vinicki
      • Buenos Aires, Argentina, C1121ABE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Baños
      • Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo MANNUCCI WALTER
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Patricio Tate
        • Contact:
        • Contact:
      • Ciudad Autonoma de Buenos Aire, Argentina, 1425
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dario Scublinsky
      • La Plata, Argentina, B1900AX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Magri
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carolina Iturralde
      • Quilmes, Argentina, B1878GEG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Velasco Zamora
      • San Miguel de Tucumán, Argentina, CP 4000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Veronica Ines Bellomio
        • Contact:
        • Contact:
      • Santa Fe, Argentina, S2000DSV
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bernardo Pons Estel
        • Contact:
        • Contact:
  • Brazil
      • Belo Horizonte, Brazil, 30150-221.
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia Neiva
      • Cuiabá, Brazil, 78020-840
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Victor Matheus Santos
      • Juiz de Fora, Brazil, 36010-570
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viviane Souza
      • Passo Fundo, Brazil, 99010-080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandre Tognon
      • Porto Alegre, Brazil, 90610-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tatiana Muller
      • Porto Alegre, Brazil, 90035-001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tamara Mucenic
        • Contact:
        • Contact:
      • Porto Alegre, Brazil, 90430-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cecilia Da Costa
      • Salvador, Brazil, 41820-020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gleison Duarte
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mariana Martins
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luciana Seguro
      • São Paulo, Brazil, 01323-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Hamazaki
  • France
      • Angers, France, 49933
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Lavigne
      • Lille, France, 59800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • eric hachulla
      • Pessac, France, 33604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Estibaliz Lazaro
      • Rennes, France, 35200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas Belhomme
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Killian
      • Toulouse, France, 31400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gregory Pugnet
  • Germany
      • Herne, Germany, 44649
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ioana Andreica
      • Lübeck, Germany, 23538
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jens Humrich
      • Mainz, Germany, 55131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Weinmann-Menke
      • Meerbusch, Germany, 40668
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefan Vordenbaeumen
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitrios Boumpas
      • Athens, Greece, 11527
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pinelopi Konstantopoulou
      • Athens, Greece, 11 527
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petros Sfikakis
      • Heraklion, Greece, 71500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • George Bertsias
      • Thessaloniki, Greece, 54642
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theodoros Dimitroulas
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Micaela Fredi
      • Ferrara, Italy, 44124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcello Govoni
      • Milan, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenzo Dagna
      • Pisa, Italy, 56100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Mosca
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giulia Pazzola
      • Rome, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Antonietta D'Agostino
      • Rozzano, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela Ceribelli
  • Japan
      • Fukuoka, Japan, 807-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ippei Miyagawa
      • Kanagawa, Japan, 252-0375
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kunihiro Yamaoka
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroko Sato
      • Osaka, Japan, 590-0197
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuji Nozaki
      • Tokyo, Japan, 104-8560
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Takehiro Nakai
        • Contact:
        • Contact:
  • Mexico
      • DF, Mexico, 14000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hilda Fragoso Loyo
      • Guadalajara Jalisco, Mexico, 44950
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge-Enrique Aguilar-Arreola
      • León, Mexico, 37000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Luis Alberto Morales Torres
      • Mexico City, Mexico, 06700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan-Manuel Martinez-Noriega
      • Mexico City, Mexico, 06726
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriela Huerta Sil
      • Monterrey Nuevo LeOn, Mexico, 64000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edmundo Hector De la Garza Ramos
      • Mérida, Mexico, 97000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Avila-Zapata
      • San Luis Potosí City, Mexico, 78200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Victor Manuel Dimas Pecina
      • Torreón, Mexico, 27000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Sicsik Ayala
    • Mexico City
      • Cuauhtémoc, Mexico City, Mexico, 06090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Conrado Garcia Garcia
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Santos
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tarek Carlos Salman Monte
      • Castellon, Spain, 12004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Arantzazu Conesa Mateos
        • Contact:
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alejandro Escudero Contreras
        • Contact:
        • Contact:
      • Murcia, Spain, 30120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nuria Lozano Rivas
      • Seville, Spain, 41014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Rodríguez Montero
      • Valladolid, Spain, 47012
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Julia Barbado Ajo
        • Contact:
        • Contact:
      • VigoPontevedra, Spain, 36213
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Maria Pego Reigosa
      • Villajoyosa, Spain, 3570
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Carlos Rosas Gomez de Salazar
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vishala Chindalore
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alexander Hu
        • Contact:
        • Contact:
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Swati Bharadwaj
      • Tucson, Arizona, United States, 85748
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jawad Bilal
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Samy Metyas
        • Contact:
        • Contact:
      • Fontana, California, United States, 92335
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Steve Lee
        • Contact:
        • Contact:
      • Fullerton, California, United States, 92835
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shirley Pang
      • Long Beach, California, United States, 90720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nathaniel Neal
      • Los Angeles, California, United States, 90211
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Wallace
      • Mission Hills, California, United States, 91345
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sue Chung
        • Contact:
        • Contact:
      • San Diego, California, United States, 92128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tania Rivera
      • Temecula, California, United States, 92592
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chandrakant Mehta
      • Tujunga, California, United States, 91042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dan La
      • Van Nuys, California, United States, 92307-2333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diraj Karnani
      • Van Nuys, California, United States, 92586
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amal Mehta
      • Whittier, California, United States, 90602
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tien-I Karleen Su
        • Contact:
        • Contact:
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Norman Gaylis
        • Contact:
        • Contact:
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodney Daniel
      • Miami, Florida, United States, 33126
        • Withdrawn
        • GSK Investigational Site
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elias Halpert
      • Tampa, Florida, United States, 33606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Priya Reddy
    • Georgia
      • Atlanta, Georgia, United States, 30152
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roel Querubin
      • Sugar Hill, Georgia, United States, 30518
        • Withdrawn
        • GSK Investigational Site
    • Illinois
      • Morton Grove, Illinois, United States, 60521
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela Crowley
      • Rockford, Illinois, United States, 60123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Husna Siddiqui
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Saravanan Thiagarajan
        • Contact:
        • Contact:
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Lindsey
      • Shreveport, Louisiana, United States, 71115
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samina Hayat
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alireza Meysami
      • Lansing, Michigan, United States, 48910
        • Completed
        • GSK Investigational Site
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haroon Sarwar
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Goddard
    • North Carolina
      • Charlotte, North Carolina, United States, 28202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gordon Lam
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rupak Thapa
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Completed
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arundathi Jayatilleke
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Pickrell
        • Contact:
        • Contact:
      • Baytown, Texas, United States, 77521
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sabeen Najam
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dhiman Basu
        • Contact:
        • Contact:
      • Fort Worth, Texas, United States, 76109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Himabindu Reddy
      • Houston, Texas, United States, 77089
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philip Waller
      • Katy, Texas, United States, 77494
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kiran Farheen
      • Plano, Texas, United States, 75024
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fehmida Zahabi-Unwala
        • Contact:
        • Contact:
      • Waco, Texas, United States, 76710
        • Withdrawn
        • GSK Investigational Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sharukh Shroff
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kurt Oelke
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  • Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal (GI), hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk.
  • Participants with history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.
  • Have an acute or chronic infection including requiring management as follows:
  • Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
  • A serious infection requiring treatment with intravenous or Intramuscular (IV/IM) antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed.
  • Confirmed active or untreated latent tuberculosis (TB):
  • Diagnosis of active TB confirmed by: 1) evidence of active TB disease from chest imaging (posterior anterior and lateral x-rays or chest computed tomography [CT]), 2) medical history and physical examination, and 3) either positive microscopy smear/culture for mycobacteria or positive TB polymerase chain reaction (PCR), i.e., Xpert. A tuberculin skin test (TST) or an interferon gamma release assay (IGRA) will be done for all participants. A positive TST or a positive (not indeterminate) IGRA TB test such as QuantiFERON-TB Gold Plus test is indicative but not required for diagnosis of active TB. A positive TST is defined as a skin induration >=5 millimeter (mm) at 48 to 72 hours (regardless of Bacillus Calmette-Guerin or other vaccination history).
  • Untreated latent tuberculosis infection (LTBI) confirmed by: 1) no evidence of active TB based on chest imaging, medical history and physical examination and laboratory evaluation of sputum; and 2) a positive TST, defined as a skin induration >5 mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin or other vaccination history); or a positive (not indeterminate) IGRA TB test such as QuantiFERON-TB Gold Plus test. Those with IGRA positive tests or positive TST who can document ongoing LTBI treatment for at least 4 weeks may be enrolled. Those with IGRA positive tests with documentation of the following may also be enrolled:
  • Successful completion of treatment for active TB.
  • Completion of treatment for LTBI (with treatment as per local practice, for example: 3 months of isoniazid and rifampin or 4 months of rifampin or 3 months weekly isoniazid and rifapentine, or 9 months of isoniazid).
  • Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms.
  • Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, Cerebrovascular accident (CVA), cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Screening.
  • Active Lupus Nephritis defined as active urinary sediment and/or proteinuria >500 milligrams (mg) per 24 hours, or equivalent using spot urine protein to creatinine ratio, requiring induction therapy not permitted by protocol.
  • Participants with patient health questionnaire (PHQ)-9 score >=10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk. NOTE: For participants with a PHQ-9 score >=10, at the Screening visit or at the day 1 visit before the first administration of the study drug, it is required that they be referred for an assessment by a mental healthcare professional (e.g., locally licensed psychiatrist, psychologist, or master's level therapist) before the investigator makes a final decision regarding suitability for enrollment.
  • Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies
  • Live or live-attenuated vaccine(s) within 35 days prior to Screening or plans to receive 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) (oral [PO])/MMF hydrochloride (IV) >2 grams (g)/day
  • Mycophenolate acid/sodium (PO) >1.44 g/day
  • Oral cyclophosphamide >2.5 mg/kilograms (kg)/day
  • Tacrolimus >0.2 mg/kg/day
  • Cyclosporine (PO) >2.5 mg/kg/day
  • Treatment within specified timeframe prior to Screening:
  • 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
  • Treatment at any time prior to Screening with any of the following:
  • Second line use of conventional immunosuppressants (ISs) or anti-malarials (AMs)
  • Commercially available Belimumab (BEL)
  • Anifrolumab
  • Rituximab or other B cell depleting therapies
  • Anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab, etanercept, infliximab)
  • Other treatments with effects on the immune system (e.g., abatacept, interleukin-1 receptor antagonist [anakinra], Janus kinase (JAK) inhibitors)
  • IV cyclophosphamide
  • IV immunoglobulin
  • Plasmapheresis Any addition of a new IS or AM, or IS or AM switch, performed more than 3 months after initiating first line therapy in response to inadequate disease control is considered second-line therapy and is therefore exclusionary. Therapy changes made due to intolerance or toxicity are not considered second-line, provided that the intolerance/toxicity is clearly documented. Any therapy changes after initiating first line therapy considered to be due to intolerance/toxicity must be reviewed and confirmed by the EAC prior to determining eligibility.
  • History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G [IgG] <400 mg/deciliter [dL]) or Immunoglobulin A (IgA) deficiency (IgA <10 mg/dL) at Screening
  • Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/cubic millimeter (mm3) (<1.0 x10^9/liter [L]) based on the Common terminology criteria for adverse events (CTCAE) version (v) 5.0
  • Alanine aminotransferase >2 x upper limit of normal (ULN)
  • Total bilirubin >1.5 x ULN; For participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN if direct bilirubin is ≤1.5xULN. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome), asymptomatic gallstones, and chronic stable hepatitis B (in whom Hepatitis D [HDV] has been excluded) or C are acceptable if participant otherwise meets entry criteria.
  • Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.
  • Positive Human immunodeficiency virus (HIV) antibody test
  • Serologic evidence of Hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), anti-hepatitis B core (HBc) and anti-HBs will be excluded as follows:
  • Participants positive for HBsAg.
  • Participants negative for HBsAg but positive for Anti-HBc and detectable hepatitis B virus (HBV) DNA, regardless of Anti-HBs antibody status.
  • Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA) test is obtained.
  • Positive Hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention. NOTE: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
  • Sensitivity to the clinical study intervention, or components thereof, or monoclonal antibodies 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 or dependence within 364 days prior to Day 1
  • Current enrolment or past participation in any other clinical study involving an investigational study intervention (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug (whichever is longer) before enrolment
  • Unable to administer clinical study intervention by subcutaneous (SC) auto-injector at home and has no other reliable resource to administer the study intervention at home.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belimumab (GSK1550188)
Participants will receive GSK1550188.
Biological: Belimumab (GSK1550188)
GSK1550188 will be administered subcutaneously.
Other Names:
  • BEL (BENLYSTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Time Frame: At Week 52
LLDAS is defined as Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than or equal to (<=) 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no new features of lupus disease activity compared with the previous assessment, Physician Global Assessment (PGA) <= 1, with a 7-day average oral prednisone equivalent dose for SLE reasons <= 7.5 milligram (mg)/day and stable treatment and without discontinuing due to lack of efficacy, dying, or taking prohibited medications.
At Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue at Week 52
Time Frame: Baseline (Day 1) and at Week 52
The FACIT-Fatigue is a 13-item participant-completed questionnaire used to assess the impact of fatigue over the previous 7 days. Item responses range from 0 (Not at All) to 4 (Very Much). The FACIT-Fatigue is scored as the sum of item responses, with range from 0 to 52, where higher scores indicate less fatigue and a better quality of life.
Baseline (Day 1) and at Week 52
Part B: Number of Participants With AEs, SAEs, and AESIs up to Week 104 and Week 156
Time Frame: Up to Week 104 and Week 156
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per the Investigator's medical or scientific judgment. AESIs will include hypersensitivity or post-injection systemic reactions, infections of special interest, malignancy, psychiatric events, and fatal events.
Up to Week 104 and Week 156
Part A: Percentage of Participants Achieving SLE Responder Index 4 (SRI4) at Week 52
Time Frame: At Week 52
SRI4 is defined as greater than or equal to (>=) 4-point reduction from baseline in SLEDAI-2K score and no worsening (increase of less than [<] 0.30 points from baseline) in PGA and no new Easy- British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new Easy-BILAG B organ domain scores compared with baseline at the time of assessment without participants discontinuing due to lack of efficacy, dying, taking prohibited medications or meeting treatment failure criteria.
At Week 52
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) for >= 25 percent (%) of time from Day 1 to Week 52
Time Frame: Day 1 and up to Week 52
LLDAS is defined as Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than or equal to (<=) 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no new features of lupus disease activity compared with the previous assessment, Physician Global Assessment (PGA) <= 1, with a 7-day average oral prednisone equivalent dose for SLE reasons <=7.5 milligram (mg)/day and stable treatment and without discontinuing due to lack of efficacy, dying, or taking prohibited medications.
Day 1 and up to Week 52
Part A: Percentage of Participants Achieving Average Oral Prednisone Equivalent Dose <= 5 mg/day at Week 52
Time Frame: At Week 52
A seven-day average oral prednisone equivalent dose <= 5 mg/day at week 52, if oral prednisone equivalent dose is greater than (>) 5 mg/day at baseline without study intervention discontinuation due to lack of efficacy, serious AE, prohibited medication intake, or treatment failure by Week 52.
At Week 52
Part A: Estimate of probability of having a Severe Flare defined as modified SELENA-SLEDAI Flare Index (SFI) at Week 52
Time Frame: At Week 52
SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA-SLEDAI flare assessment that were triggered only by an increase in SLEDAI-2K score to >12). Change in SELENA SLEDAI instrument score of greater than 12.
At Week 52
Part A: Percentage of Participants Achieving a >= 50% Improvement in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score at Week 52
Time Frame: At Week 52
The CLASI is used to assess the cutaneous lesions of SLE and consists of 2 separate scores: the activity score and the damage score. The activity score evaluates erythema, scale/hypertrophy, mucous membrane lesions, recent hair loss, and nonscarring alopecia, measured at 13 anatomical sites on the skin. The total activity score ranges from 0 to 70. Higher scores indicate greater disease activity and severity in SLE.
At Week 52
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Time Frame: Up to Week 52
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per the Investigator's medical or scientific judgment. AESIs will include hypersensitivity or post-injection systemic reactions, infections of special interest, malignancy, psychiatric events, and fatal events.
Up to Week 52
Part B: Percentage of Participants Achieving Definition of Remission in SLE (DORIS) Remission at Week 104
Time Frame: At Week 104
DORIS remission is defined as clinical SLEDAI-2K equal to (=) 0 (excluding anti- double stranded deoxyribonucleic acid [dsDNA] and complement); and PGA < 0.5; and prednisone (or equivalent dose) < 5 mg/day on stable anti-malarial (AM), immunosuppressants (ISs) and biologic therapy.
At Week 104
Part B: Percentage of Participants Maintaining Systematic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) of 0
Time Frame: Up to Week 156
The SDI measures irreversible changes occurring since the diagnosis of SLE. The questionnaire contains 39 items covering 12 different organ systems. Individual ranges for organ systems are ocular: 0-2, neuropsychiatric: 0-6; renal: 0-3; pulmonary: 0-5; cardiovascular: 0-6; peripheral vascular: 0-5; gastrointestinal: 0-5; musculoskeletal: 0-6; skin: 0-3; endocrine (diabetes): 0-1; gonadal: 0-1; and malignancies: 0-2. The SDI score is calculated by summing the individual scores for 12 organ systems and ranges from 0 (no damage) to 45 (increasing disease damage) where higher score indicates increasing disease damage severity.
Up to Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 29, 2029

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219240
  • 2023-509146-35 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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