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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01484496
• Date of registration: 28/11/2011
• Prospective Registration: No
• Primary sponsor: Human Genome Sciences Inc., a GSK Company
• Public title: A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) BLISS-SC
• Scientific 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)
• Date of first enrolment: November 16, 2011
• Target sample size: 839
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01484496
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Belimumab 200 mg SC

Drug: Standard therapy

Biological: Placebo

Primary Outcome(s)

Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline [Time Frame: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52]

Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [Time Frame: Baseline (Day 0, prior to dosing) to Week 52]

Secondary ID(s)

HGS1006-C1115

112341

2011-003814-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 25/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01484496