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

NCT06411249 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2192402023-509146-35-00
• Study Type: interventional
• Target: 350
• Locations: 11 countries
• Sites: 113

Brief 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 initial SLE therapy.

Conditions

Systemic Lupus Erythematosus

Keywords

Belimumab; Benlysta; Efficacy; Safety; Early Use; Systemic Lupus Erythematosus; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) 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 Outcomes (10)

• Part A: Percentage of Participants Achieving SLE Responder Index 4 (SRI4) at Week 52

  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

  Day 1 and up to Week 52

• Part A: Percentage of Participants Achieving Average Oral Prednisone Equivalent Dose ≤ 5 mg/day at 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

  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

  At Week 52

Study Arms (1)

Belimumab (GSK1550188)

EXPERIMENTAL

Participants will receive GSK1550188.

Drug: Belimumab (GSK1550188)

Interventions

Belimumab (GSK1550188) DRUG

GSK1550188 will be administered subcutaneously.

Also known as: BEL (BENLYSTA)

Belimumab (GSK1550188)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) less than or equal 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (113)

GSK Investigational Site

Anniston, Alabama, 36207, United States

RECRUITING

GSK Investigational Site

Flagstaff, Arizona, 86001, United States

RECRUITING

GSK Investigational Site

Mesa, Arizona, 85210, United States

RECRUITING

GSK Investigational Site

Tucson, Arizona, 85748, United States

RECRUITING

GSK Investigational Site

Covina, California, 91722, United States

RECRUITING

GSK Investigational Site

Fontana, California, 92335, United States

RECRUITING

GSK Investigational Site

Fullerton, California, 92835, United States

RECRUITING

GSK Investigational Site

Long Beach, California, 90720, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90211, United States

RECRUITING

GSK Investigational Site

Mission Hills, California, 91345, United States

RECRUITING

GSK Investigational Site

San Diego, California, 92128, United States

RECRUITING

GSK Investigational Site

Temecula, California, 92592, United States

RECRUITING

GSK Investigational Site

Tujunga, California, 91042, United States

RECRUITING

GSK Investigational Site

Van Nuys, California, 92307-2333, United States

RECRUITING

GSK Investigational Site

Van Nuys, California, 92586, United States

RECRUITING

GSK Investigational Site

Whittier, California, 90602, United States

RECRUITING

GSK Investigational Site

Aventura, Florida, 33180, United States

RECRUITING

GSK Investigational Site

Clearwater, Florida, 33765, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33126, United States

WITHDRAWN

GSK Investigational Site

Tamarac, Florida, 33321, United States

RECRUITING

GSK Investigational Site

Tampa, Florida, 33606, United States

RECRUITING

GSK Investigational Site

Atlanta, Georgia, 30152, United States

RECRUITING

GSK Investigational Site

Sugar Hill, Georgia, 30518, United States

WITHDRAWN

GSK Investigational Site

Morton Grove, Illinois, 60521, United States

RECRUITING

GSK Investigational Site

Rockford, Illinois, 60123, United States

RECRUITING

GSK Investigational Site

Baton Rouge, Louisiana, 70836, United States

RECRUITING

GSK Investigational Site

New Orleans, Louisiana, 70112, United States

RECRUITING

GSK Investigational Site

Shreveport, Louisiana, 71115, United States

RECRUITING

GSK Investigational Site

Detroit, Michigan, 48202, United States

RECRUITING

GSK Investigational Site

Lansing, Michigan, 48910, United States

COMPLETED

GSK Investigational Site

Sparta, New Jersey, 07871, United States

RECRUITING

GSK Investigational Site

Brooklyn, New York, 11201, United States

RECRUITING

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

RECRUITING

GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

RECRUITING

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

COMPLETED

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

GSK Investigational Site

Austin, Texas, 78745, United States

RECRUITING

GSK Investigational Site

Baytown, Texas, 77521, United States

RECRUITING

GSK Investigational Site

Colleyville, Texas, 76034, United States

RECRUITING

GSK Investigational Site

Fort Worth, Texas, 76109, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77089, United States

RECRUITING

GSK Investigational Site

Katy, Texas, 77494, United States

RECRUITING

GSK Investigational Site

Plano, Texas, 75024, United States

RECRUITING

GSK Investigational Site

Waco, Texas, 76710, United States

WITHDRAWN

GSK Investigational Site

Danville, Virginia, 24541, United States

RECRUITING

GSK Investigational Site

Glendale, Wisconsin, 53217, United States

RECRUITING

GSK Investigational Site

Berazategui, 1884, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1406AGA, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1425, Argentina

RECRUITING

GSK Investigational Site

La Plata, B1900AX, Argentina

RECRUITING

GSK Investigational Site

Mar del Plata, 7600, Argentina

RECRUITING

GSK Investigational Site

Quilmes, B1878GEG, Argentina

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, CP 4000, Argentina

RECRUITING

GSK Investigational Site

Santa Fe, S2000DSV, Argentina

RECRUITING

GSK Investigational Site

Belo Horizonte, 30150-221., Brazil

RECRUITING

GSK Investigational Site

Cuiabá, 78020-840, Brazil

RECRUITING

GSK Investigational Site

Juiz de Fora, 36010-570, Brazil

RECRUITING

GSK Investigational Site

Passo Fundo, 99010-080, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90035-001, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90430-001, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90610-000, Brazil

RECRUITING

GSK Investigational Site

Salvador, 41820-020, Brazil

RECRUITING

GSK Investigational Site

São José do Rio Preto, 15090-000, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 01323-001, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 05403-000, Brazil

RECRUITING

GSK Investigational Site

Angers, 49933, France

RECRUITING

GSK Investigational Site

Lille, 59800, France

RECRUITING

GSK Investigational Site

Pessac, 33604, France

RECRUITING

GSK Investigational Site

Rennes, 35200, France

RECRUITING

GSK Investigational Site

Saint-Priest-en-Jarez, 42270, France

RECRUITING

GSK Investigational Site

Toulouse, 31400, France

RECRUITING

GSK Investigational Site

Herne, 44649, Germany

RECRUITING

GSK Investigational Site

Lübeck, 23538, Germany

RECRUITING

GSK Investigational Site

Mainz, 55131, Germany

RECRUITING

GSK Investigational Site

Mainz, 55131, Germany

RECRUITING

GSK Investigational Site

Meerbusch, 40668, Germany

RECRUITING

GSK Investigational Site

Athens, 11 527, Greece

RECRUITING

GSK Investigational Site

Athens, 11527, Greece

RECRUITING

GSK Investigational Site

Athens, 12462, Greece

RECRUITING

GSK Investigational Site

Heraklion, 71500, Greece

RECRUITING

GSK Investigational Site

Thessaloniki, 54642, Greece

RECRUITING

GSK Investigational Site

Brescia, 25123, Italy

RECRUITING

GSK Investigational Site

Ferrara, 44124, Italy

RECRUITING

GSK Investigational Site

Milan, 20132, Italy

RECRUITING

GSK Investigational Site

Pisa, 56100, Italy

RECRUITING

GSK Investigational Site

Reggio Emilia, 42123, Italy

RECRUITING

GSK Investigational Site

Rome, 00168, Italy

RECRUITING

GSK Investigational Site

Rozzano, 20089, Italy

RECRUITING

GSK Investigational Site

Fukuoka, 807-8556, Japan

RECRUITING

GSK Investigational Site

Kanagawa, 252-0375, Japan

RECRUITING

GSK Investigational Site

Miyagi, 980-8574, Japan

RECRUITING

GSK Investigational Site

Osaka, 590-0197, Japan

RECRUITING

GSK Investigational Site

Tokyo, 104-8560, Japan

RECRUITING

GSK Investigational Site

Cuauhtémoc, Mexico City, 06090, Mexico

RECRUITING

GSK Investigational Site

DF, 14000, Mexico

RECRUITING

GSK Investigational Site

Guadalajara Jalisco, 44950, Mexico

RECRUITING

GSK Investigational Site

León, 37000, Mexico

RECRUITING

GSK Investigational Site

Mexico City, 06700, Mexico

RECRUITING

GSK Investigational Site

Mexico City, 06726, Mexico

RECRUITING

GSK Investigational Site

Mérida, 97000, Mexico

RECRUITING

GSK Investigational Site

Monterrey Nuevo LeOn, 64000, Mexico

RECRUITING

GSK Investigational Site

San Luis Potosí City, 78200, Mexico

RECRUITING

GSK Investigational Site

Torreón, 27000, Mexico

RECRUITING

GSK Investigational Site

Almada, 2805-267, Portugal

RECRUITING

GSK Investigational Site

Barcelona, 08003, Spain

RECRUITING

GSK Investigational Site

Córdoba, 14004, Spain

RECRUITING

GSK Investigational Site

Murcia, 30120, Spain

RECRUITING

GSK Investigational Site

Seville, 41014, Spain

RECRUITING

GSK Investigational Site

Valladolid, 47012, Spain

RECRUITING

GSK Investigational Site

VigoPontevedra, 36213, Spain

RECRUITING

GSK Investigational Site

Villajoyosa, 3570, Spain

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 29, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

PT (1); IT (7); FR (6); BR (11); AR (10); US (46); JP (5); ME (10); DE (5); GR (5); ES (7)