RECRUITING

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

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Conditions

Systemic Lupus ErythematosusBelimumabBenlystaEfficacySafetyEarly UseAutoimmune Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-04
Study Completion:2029-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06411249

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented clinical diagnosis of SLE within 2 years of signing the informed consent according to the American College of Rheumatology (ACR) SLE classification criteria 2019
  2. * Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer ≥1:80 and/or a positive anti-
  3. * Active SLE defined as:
  4. * Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score greater than (\>) 4, OR
  5. * Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) ≤4 and prednisone or equivalent dose ≥10 milligram per day (mg/day)
  6. * The Systematic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) = 0 at Screening
  7. * 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:
  8. * Not a Women of childbearing potential (WOCBP) OR
  9. * Is a WOCBP and using a contraceptive method that is highly effective
  10. * Capable of giving signed informed consent
  1. * 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.
  2. * 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.
  3. * Have an acute or chronic infection including requiring management as follows:
  4. * Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
  5. * 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.
  6. * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior, anterior, and lateral), and TB testing: either a positive tuberculin skin test (TST); defined as a skin induration ≥5millimeter (mm) at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) interferon gamma release assay TB test.
  7. * Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms.
  8. * 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.
  9. * Lupus kidney disease defined by proteinuria \>6 gram (g)/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine \>2.5 milligram per decilitre (mg/dL) or have active LN requiring induction therapy within 35 days of Screening.
  10. * 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/or any suicidal ideation in the last 2 months or who, in the investigator's opinion, pose a significant suicide risk.
  11. * Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies
  12. * 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
  13. * Chronic oral steroid use for a non-SLE disorder at the Screening study visit (e.g., for asthma). Inhaled steroid use will be allowed.
  14. * Treatment at or prior to Screening study visit:
  15. * Azathioprine (AZA) \>200 mg/day
  16. * Methotrexate (MTX) (any formulation) \>25 mg/week
  17. * Mycophenolate mofetil (MMF) (PO)/MMF hydrochloride (IV) \>2 g/day
  18. * Mycophenolate acid/sodium (PO) \>1.44 g/day
  19. * Oral cyclophosphamide \>2.5 mg/kg/day
  20. * Tacrolimus \>0.2 mg/kg/day
  21. * Cyclosporine (PO) \>2.5 mg/kg/day
  22. * Second line use of conventional ISs or AMs
  23. * Commercially available Belimumab (BEL)
  24. * Anifrolumab
  25. * Rituximab or other B cell depleting therapies
  26. * Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab)
  27. * Other treatments with effects on the immune system (e.g., abatacept, interleukin-1 receptor antagonist \[anakinra\], Janus kinase (JAK) inhibitors)
  28. * IV cyclophosphamide
  29. * IV immunoglobulin
  30. * Plasmapheresis
  31. * Intra-articular, IM, or IV corticosteroids within 6 weeks of Day 1
  32. * Daily use of \>1 Nonsteroidal anti-inflammatory (NSAID) within 2 weeks prior to Day 1
  33. * History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G \[IgG\] \<400 mg/dL) or Immunoglobulin A (IgA) deficiency (IgA \<10 mg/dL)
  34. * 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 criteria for adverse events (CTCAE) v5.0 Alanine aminotransferase \>2 x upper limit of normal (ULN)
  35. * Total bilirubin \>1.5 x ULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\])
  36. * 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.
  37. * Positive Human immunodeficiency virus (HIV) antibody test
  38. * 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.
  39. * 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.
  40. * 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.
  41. * 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
  42. * Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1
  43. * 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
  44. * Unable to administer clinical study intervention by subcutaneous (SC) auto-injector and has no other reliable resource to administer the study intervention.

Contacts and Locations

Study Contact

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

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Anniston, Alabama, 36207
United States
GSK Investigational Site
Flagstaff, Arizona, 86001
United States
GSK Investigational Site
Mesa, Arizona, 85210
United States
GSK Investigational Site
Tucson, Arizona, 85748
United States
GSK Investigational Site
Apple Valley, California, 92307-2333
United States
GSK Investigational Site
Beverly Hills, California, 90211
United States
GSK Investigational Site
Covina, California, 91722
United States
GSK Investigational Site
Fontana, California, 92335
United States
GSK Investigational Site
Fullerton, California, 92835
United States
GSK Investigational Site
Los Angeles, California, 90033
United States
GSK Investigational Site
Menifee, California, 92586
United States
GSK Investigational Site
Mission Hills, California, 91345
United States
GSK Investigational Site
Tujunga, California, 91042
United States
GSK Investigational Site
Whittier, California, 90602
United States
GSK Investigational Site
Denver, Colorado, 80230
United States
GSK Investigational Site
Aventura, Florida, 33180
United States
GSK Investigational Site
Clearwater, Florida, 33765
United States
GSK Investigational Site
Miami, Florida, 33126
United States
GSK Investigational Site
Tamarac, Florida, 33321
United States
GSK Investigational Site
Marietta, Georgia, 30152
United States
GSK Investigational Site
Sugar Hill, Georgia, 30518
United States
GSK Investigational Site
Chicago, Illinois, 60612
United States
GSK Investigational Site
Elgin, Illinois, 60123
United States
GSK Investigational Site
Hinsdale, Illinois, 60521
United States
GSK Investigational Site
Baton Rouge, Louisiana, 70836
United States
GSK Investigational Site
New Orleans, Louisiana, 32204
United States
GSK Investigational Site
Shreveport, Louisiana, 71115
United States
GSK Investigational Site
Detroit, Michigan, 48202
United States
GSK Investigational Site
Lansing, Michigan, 48910
United States
GSK Investigational Site
Sparta, New Jersey, 07871
United States
GSK Investigational Site
Brooklyn, New York, 11201
United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157
United States
GSK Investigational Site
Minot, North Dakota, 58701
United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
United States
GSK Investigational Site
Austin, Texas, 78745
United States
GSK Investigational Site
Baytown, Texas, 77521
United States
GSK Investigational Site
Colleyville, Texas, 76034
United States
GSK Investigational Site
Fort Worth, Texas, 76109
United States
GSK Investigational Site
Houston, Texas, 77089
United States
GSK Investigational Site
Katy, Texas, 77494
United States
GSK Investigational Site
Pearland, Texas, 77584
United States
GSK Investigational Site
Plano, Texas, 75024
United States
GSK Investigational Site
Waco, Texas, 76710
United States
GSK Investigational Site
Danville, Virginia, 24541
United States
GSK Investigational Site
Glendale, Wisconsin, 53217
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-06-04
Study Completion Date2029-05-29

Study Record Updates

Study Start Date2024-06-04
Study Completion Date2029-05-29

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus