Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Completed · Phase 4 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

Key facts

Study ID

NCT01632241

Run by

Human Genome Sciences Inc., a GSK Company

People needed

503

Starts

2013-02-19

Expected to finish

2019-01-28

Last updated by the study team

2021-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age.
• Self-identified black race.
• Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria
• Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening
• Have 2 unequivocally positive autoantibody test results defined as a positive antinuclear antibody (ANA) test [i.e., titer >= 1:80 by human epithelial cell line 2 (HEp-2) immunofluorescence assay (IFA) and/or positive enzyme immunoassay (EIA)] and/or a positive anti- double stranded deoxyribonucleic acid (dsDNA) (>= 30 international units [IU]/milliliter [mL]) serum antibody test as follows:
• From 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results, OR
• One positive historical test result and 1 positive test result during the screening period.
• Historical documentation of a positive ANA test (e.g., HEp-2 IFA or EIA) or anti-dsDNA (eg, anti-dsDNA by any validated commercial assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive versus negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted.
• On a stable SLE treatment regimen consisting of any of the following medications (alone or in combination) for a period of at least 30 days prior to Day 0 (i.e., day of 1st dose of study agent):
• Corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day): For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 40 mg/day (prednisone or prednisone equivalent). For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 7.5 to 40 mg/day (prednisone or prednisone equivalent). For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
• Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, mizoribine, or thalidomide.
• Anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Note:
• Pre-existing SLE medications must be stable for at least 30 days prior to Day 0.
• Corticosteroids may be added as new medication or their doses adjusted only up to 30 days prior to Day 0.
• New SLE therapy other than corticosteroids must not be added within 60 days of Day 0.
• A female subject is eligible to enter the study if she is:
• Not pregnant or nursing;
• Of non-childbearing potential defined as: pre-menopausal females with a documented tubal ligation, hysterectomy, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, or documented bilateral oophorectomy, OR postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile [e.g., > 45 years, in the absence of hormone replacement therapy or other cause for amenorrhea]; in questionable cases obtain a blood sample for follicle stimulating hormone (FSH) and estradiol simultaneously to confirm. Diagnostic levels for FSH and estradiol vary by specific laboratories/assays;
• OR is of child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotrophin (hCG) test at screening and urine hCG test prior to dosing AND agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks following the last dose of study agent.
• OR has only same-sex partners, when this is her preferred and usual lifestyle.
• Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).

You may not qualify if…

• Have received treatment with anti-B lymphocyte stimulator (BLyS) [belimumab] at any time.
• Have received any of the following within 364 days of Day 0:
• Abatacept
• Other B cell targeted therapy (e.g., rituximab, other anti-cluster of differentiation [CD] 20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, or anti-B-cell activating factor [BAFF] (LY2127399).
• A biologic investigational agent other than B cell targeted therapy (e.g., abetimus sodium, anti-CD40L antibody [BG9588/IDEC-131]).
• Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 364 days of Day 0. (Topical or inhaled steroids are permitted.)
• Have received any of the following within 90 days of Day 0:
• Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab).
• Intravenous (IV) cyclophosphamide
• Interleukin-1 receptor antagonist (anakinra).
• Intravenous immunoglobulin (IVIG).
• High dose prednisone or equivalent (> 100 mg/day).
• Plasmapheresis.
• Have received any of the following within 60 days of Day 0:
• A non-biologic investigational agent.
• Any new immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID Note: New inhaled and topical steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for < 1 week is allowed.
• Any steroid injection (e.g., intramuscular, intraarticular, or intravenous).
• Have received any of the following within 30 days of Day 0:
• A live vaccine.
• A change in dose of a corticosteroid, other immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID
• Have severe lupus kidney disease (defined by proteinuria > 6 grams/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/deciliter [dL]), or have severe active nephritis requiring acute therapy not permitted by protocol (e.g., IV cyclophosphamide within 90 days of Day 0), or have required hemodialysis or high-dose prednisone (> 100 mg/day) within 90 days of Day 0.
• 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 Day 0.
• Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
• Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
• Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.

Where it is running

• GSK Investigational Site — Covina, California, United States
• GSK Investigational Site — La Palma, California, United States
• GSK Investigational Site — Lakewood, California, United States
• GSK Investigational Site — Los Alamitos, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Murrieta, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Bridgeport, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Aventura, Florida, United States
• GSK Investigational Site — DeBary, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Longwood, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami Lakes, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Tamarac, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Duluth, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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