Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)
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ClinicalTrials.gov Identifier: NCT01639339 |
Recruitment Status :
Completed
First Posted : July 12, 2012
Results First Posted : July 7, 2020
Last Update Posted : March 19, 2021
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Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Lupus Nephritis |
Interventions |
Biological: Placebo plus standard therapy Biological: Belimumab 10 mg/kg plus standard therapy Drug: Standard therapy |
Enrollment | 448 |
Participant Flow
Recruitment Details | This study evaluated safety and efficacy of intravenous (IV) belimumab 10 mg/kg plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. This was a Phase 3, multi-center, multi-national study consisting of a randomized, double-blind, placebo-controlled period and an open-label extension period. The study was conducted in 21 countries. |
Pre-assignment Details | A total of 797 participants were screened of which 349 participants failed screening and 448 participants were randomized in double-blind period. In open-label period, a total of 257 participants were enrolled of which 2 participants did not receive open-label study treatment and 255 participants received open-label belimumab. |
Arm/Group Title | Placebo to Belimumab 10 mg/kg | Belimumab 10 mg/kg to Belimumab 10 |
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Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. | Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. |
Period Title: Double-blind Period (Up to Week 104) | ||
Started | 224 | 224 |
Completed | 170 | 186 |
Not Completed | 54 | 38 |
Reason Not Completed | ||
Withdrawal by Subject | 26 | 19 |
Physician Decision | 11 | 5 |
Lost to Follow-up | 5 | 4 |
Protocol Violation | 0 | 2 |
Lack of Efficacy | 2 | 1 |
Adverse Event | 10 | 7 |
Period Title: Open-label Period (Up to Week 28) | ||
Started | 123 [1] | 132 |
Completed | 122 | 124 |
Not Completed | 1 | 8 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 2 |
Lost to Follow-up | 0 | 1 |
Protocol Violation | 0 | 1 |
Adverse Event | 1 | 4 |
[1]
Of the 356 participants who completed the double-blind period, 279 were eligible for open-label treatment. As enrolling into the open-label period was optional, only 257 participants enrolled, of whom 255 started open-label treatment.
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Baseline Characteristics
Arm/Group Title | Placebo to Belimumab 10 mg/kg | Belimumab 10 mg/kg to Belimumab 10 | Total | |
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Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. | Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. | Total of all reporting groups | |
Overall Number of Baseline Participants | 224 | 224 | 448 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 224 participants | 224 participants | 448 participants | |
33.0 (10.64) | 33.7 (10.73) | 33.4 (10.68) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 224 participants | 224 participants | 448 participants | |
Female |
196 87.5%
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198 88.4%
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394 87.9%
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Male |
28 12.5%
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26 11.6%
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54 12.1%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 224 participants | 224 participants | 448 participants |
American Indian (AI) or Alaska Native (AN) |
6 2.7%
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4 1.8%
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10 2.2%
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Asian-Central/South Asian Heritage (H) |
2 0.9%
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3 1.3%
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5 1.1%
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Asian-Japanese/East Asian/Southeast Asian H |
107 47.8%
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112 50.0%
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219 48.9%
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Mixed Asian |
1 0.4%
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0 0.0%
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1 0.2%
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Black or African American (AA) |
31 13.8%
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30 13.4%
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61 13.6%
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White/Caucasian/European H |
71 31.7%
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72 32.1%
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143 31.9%
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White/Caucasian/Arabic/North African H |
4 1.8%
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1 0.4%
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5 1.1%
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Multiple-AA/African H and AI or AN and White |
1 0.4%
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1 0.4%
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2 0.4%
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Multiple-Asian and White |
1 0.4%
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1 0.4%
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2 0.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) |
ClinicalTrials.gov Identifier: | NCT01639339 |
Other Study ID Numbers: |
114054 2011-004570-28 ( EudraCT Number ) |
First Submitted: | July 10, 2012 |
First Posted: | July 12, 2012 |
Results First Submitted: | June 17, 2020 |
Results First Posted: | July 7, 2020 |
Last Update Posted: | March 19, 2021 |