A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01484496
First received: November 28, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Placebo plus standard therapy
Biological: Belimumab 200 mg SC plus standard therapy
Drug: Standard therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • SLE Responder Index (SRI) response rate [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]

    A patient that has an SRI response has all 3 of the following:

    • ≥4 point reduction from baseline in SELENA SLEDAI score,

    AND

    • No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA),

    AND

    • No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52).



Secondary Outcome Measures:
  • Time to first severe flare (SLE Flare Index) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Reduction in prednisone dose [ Time Frame: Baseline, Weeks 40-52 ] [ Designated as safety issue: No ]
    Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 in subjects receiving greater than 7.5 mg/day at baseline.


Estimated Enrollment: 816
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Biological: Placebo plus standard therapy
Placebo plus standard therapy
Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Experimental: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Biological: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy
Other Name: BENLYSTA™
Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Detailed Description:

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

  Eligibility

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

Inclusion Criteria:

  1. At least 18 years of age.
  2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  3. Active SLE disease.
  4. Autoantibody-positive.
  5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
  3. Have received treatment an investigational biological agent in the past year.
  4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
  5. Have severe active lupus kidney disease.
  6. Have severe active central nervous system (CNS) lupus.
  7. Have required management of acute or chronic infections within the past 60 days.
  8. Have current drug or alcohol abuse or dependence.
  9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.
  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: NCT01484496

Locations
United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32806-6264
United States, Maryland
GSK Investigational Site
Hagerstown, Maryland, United States, 21740
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01484496     History of Changes
Other Study ID Numbers: 112341, 2011-003814-18, HGS1006-C1115
Study First Received: November 28, 2011
Last Updated: February 6, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Colombia: INVIMA
Germany: Paul-Ehrlich-Institut
Bulgaria: Bulgarian Drug Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Croatia: Agency for Medicinal Product and Medical Devices
Hungary: National Institute of Pharmacy
Malaysia: Ministry of Health
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
Taiwan: Department of Health
Italy: Ministry of Health
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Denmark: Danish Medicines Agency
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
France: National Medication and Health Products Sagety Agency
Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Subcutaneous
Lupus
Systemic Lupus Erythematosus
SLE
Belimumab
Autoimmune Disease
Antibodies

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 August 21, 2014