Last updated: 07/17/2024 15:29:08
GSK1550188 A 52 week study of belimumab versus placebo in the treatment of subjects with systemic lupus erythematosus (SLE) located in Northeast Asia
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percent of participants achieving systemic lupus erythematosus (SLE) responder index (SRI) response rate at Week 52.
Timeframe: Week 52
Secondary outcomes:
Percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score at Week 52.
Timeframe: Baseline (Day 0) and Week 52
Percent of participants with SRI7 response at Week 52.
Timeframe: Baseline (Day 0) and Week 52
Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent from baseline over 52 Weeks.
Timeframe: Week 52
Time to first severe SLE flare index (SFI) flare over 52 weeks.
Timeframe: 52 weeks
Interventions:
Drug: Belimumab
Drug: Placebo
Enrollment:
709
Observational study model:
Not applicable
Primary completion date:
2015-15-09
Time perspective:
Not applicable
Clinical publications:
Fengchun Zhang, Sang-Cheol Bae, Damon Bass, Myron Chu, Sally Egginton, David Gordon, David Roth, Jie Zheng, Yoshiya Tanaka. A pivotal Phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan, and South Korea. Ann Rheum Dis. 2018;77(3):355-363.
Hermine Brunner, Carlos Abud-Mendoza, Masaaki Mori, Clarissa Pilkington, Reema Syed, Syuij Takei, Diego Viola, Richard Furie, Sandra Navarra, Fengchun Zhang, Damon Bass, Gina Eriksson, Anne Hammer, Beulah Ji, Mo Okily, David Roth, Holly Quasny, Nicolino Ruperto.Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison.RMD Open.2021;7(e001747)
DOI: 10.1136/rmdopen-2021-001747
PMID: 34531304
Xuan Zhou, Tsung-I Lee, Min Zhu, Peiming Ma.Prediction of Belimumab Pharmacokinetics to Chinese Pediatric Patients with Systemic Lupus Erythematosus.Drugs R D.2021;
DOI: 10.1007/s40268-021-00363-2
PMID: 34628605
Fengchun Zhang, Jie Zheng, Yang Li, Guochun Wang, Mingjun Wang, Yin Su, Jieruo Gu, Xingfu Li, Damon Bass, Myron Chu, Paula Curtis, Kathleen DeRose, Regina Kurrasch, Jenny Lowe, Paige Meizlik, David A Roth.Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years.RMD Open.2022;8(1):e001669
DOI: 35428697
PMID: 10.1136/rmdopen-2021-001669
Jie Zheng, Jieruo Gu, Yin Su, Yang Li, Xingfu Li, Cui Xiong, Hua Cao, Holly Quasny, Myron Chu, Paula Curtis, Kathleen DeRose, Regina Kurrasch, Paige Meizlik, David A Roth, Fengchun Zhang .Efficacy of belimumab in patients with systemic lupus erythematosus from North East Asia: Results of exploratory subgroup analyses.Mod Rheumatol.2022;
DOI: 10.1093/mr/roac076
PMID: 36208293
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Human Genome Sciences
Study date(s)
May 2011 to September 2018
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Age 18 years and older.
- Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
- Have received treatment with any B cell targeted therapy at any time.
- Have received a biologic investigational agent in the past year.
Inclusion and 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.
Trial location(s)
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-15-09
Actual study completion date
2018-21-09
Plain language summaries
Summary of results in plain language
Available language(s): Korean, Chinese (Simplified), English (UK), Japanese
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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