GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by GlaxoSmithKline
Sponsor:
Collaborator:
Human Genome Sciences Inc., a GSK Company
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01345253
First received: April 28, 2011
Last updated: July 11, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Belimumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • SLE Responder Index (SRI) Response Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    At Week 52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment.


Secondary Outcome Measures:
  • Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • SLE Responder Index (SRI) 7 Response Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    At Week 52, the percent of subjects with ≥ 7 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment.

  • Number of days of daily prednisone dose ≤ 7.5 mg/day and/or reduced by 50% from baseline over 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to severe SFI flare over 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: May 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab
10mg/kg
Drug: Belimumab
10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
Placebo Comparator: Placebo
placebo
Drug: Placebo
Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Detailed Description:

The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older.
  • Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
  • Have active SLE disease.
  • Have positive anti-nuclear antibody (ANA) test results.
  • Are on a stable SLE treatment regimen.
  • Females of childbearing age are willing to use appropriate contraception

Exclusion Criteria:

  • Have received treatment with any B cell targeted therapy at any time.
  • Have received a biologic investigational agent in the past year.
  • Have received 3 or more courses of systemic corticosteroids in the past year.
  • Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have had a major organ transplant.
  • Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
  • Have a planned surgical procedure.
  • Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
  • Have required management of acute or chronic infections in the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
  • Have an IgA deficiency.
  • Have severe laboratory Abnormalities.
  • Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
  • Suicidal behavior or ideation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345253

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 44 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Human Genome Sciences Inc., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01345253     History of Changes
Other Study ID Numbers: 113750
Study First Received: April 28, 2011
Last Updated: July 11, 2013
Health Authority: Korea: Food and Drug Administration
China: Food and Drug Administration
China: Ethics Review Board
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
SLEDAI
Asia
placebo
BLys
PGA
BILAG
systemic lupus erythematosus
SELENA
Lupus
SRI
efficacy
B cell
SLE Flare Index
belimumab
safety
phase III
B lymphocyte

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014