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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01345253
• Date of registration: 28/04/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
• Scientific title: GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
• Date of first enrolment: May 23, 2011
• Target sample size: 709
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01345253
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China, Japan, Korea, Republic of

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Belimumab

Drug: Placebo

Primary Outcome(s)

Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase. [Time Frame: Week 52]

Secondary Outcome(s)

Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase. [Time Frame: Baseline (Day 0) and Week 52]

Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase. [Time Frame: 52 weeks]

Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase. [Time Frame: Baseline (Day 0) and Week 52]

Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase [Time Frame: Weeks 24 and 48 for Years 2, 3, 4, 5 and 6]

Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase. [Time Frame: Week 52]

Secondary ID(s)

113750

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Human Genome Sciences Inc.

Results

• Results available: Yes
• Date Posted: 02/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01345253