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

NCT01345253 | Completed Phase 3 Results

• 1 other identifier: 113750
• Study Type: interventional
• Target: 709
• Locations: 3 countries
• Sites: 47

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLEDAI; Asia; placebo; BLys; PGA; BILAG; systemic lupus erythematosus; SELENA; Lupus; SRI; efficacy; B cell; SLE Flare Index; belimumab; safety; phase III; B lymphocyte

Outcome Measures

Primary Outcomes (1)

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

  SRI response is a composite index, defined as the percent of participants with \>=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of \< 0.30 points from Baseline) in physicians 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 (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

  Week 52

Secondary Outcomes (5)

• Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.

  Baseline (Day 0) and Week 52

• Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.

  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 for Double-blind Phase.

  Week 52

• Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.

  52 weeks

• Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase

  Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

Study Arms (2)

Belimumab

EXPERIMENTAL

10mg/kg

Drug: Belimumab

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Belimumab DRUG

10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Belimumab

Placebo DRUG

Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Human Genome Sciences Inc.: collaborator

Study Sites (47)

GSK Investigational Site

Hefei, Anhui, 230001, China

Location

GSK Investigational Site

Guangzhou, Guangdong, 510080, China

Location

GSK Investigational Site

Guangzhou, Guangdong, 510260, China

Location

GSK Investigational Site

Guangzhou, Guangdong, 510630, China

Location

GSK Investigational Site

Harbin, Heilongjiang, 150001, China

Location

GSK Investigational Site

Changsha, Hunan, 410008, China

Location

GSK Investigational Site

Changsha, Hunan, 410011, China

Location

GSK Investigational Site

Nanjing, Jiangsu, 210029, China

Location

GSK Investigational Site

Suzhou, Jiangsu, 215006, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710032, China

Location

GSK Investigational Site

Jinan, Shandong, 250012, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Kunming, Yunnan, 650101, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310009, China

Location

GSK Investigational Site

Beijing, 100029, China

Location

GSK Investigational Site

Beijing, 100032, China

Location

GSK Investigational Site

Beijing, 100044, China

Location

GSK Investigational Site

Chongqing, 400038, China

Location

GSK Investigational Site

Shanghai, 200001, China

Location

GSK Investigational Site

Shanghai, 200003, China

Location

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Shanghai, 200433, China

Location

GSK Investigational Site

Tianjin, 300052, China

Location

GSK Investigational Site

Chiba, 275-8580, Japan

Location

GSK Investigational Site

Ehime, 791-0295, Japan

Location

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 810-8563, Japan

Location

GSK Investigational Site

Hiroshima, 730-8619, Japan

Location

GSK Investigational Site

Hiroshima, 739-0002, Japan

Location

GSK Investigational Site

Hokkaido, 060-8604, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hyōgo, 675-8545, Japan

Location

GSK Investigational Site

Miyagi, 980-8574, Japan

Location

GSK Investigational Site

Nagasaki, 852-8501, Japan

Location

GSK Investigational Site

Nagasaki, 857-1195, Japan

Location

GSK Investigational Site

Okayama, 710-0824, Japan

Location

GSK Investigational Site

Okinawa, 901-0243, Japan

Location

GSK Investigational Site

Tochigi, 321-0293, Japan

Location

GSK Investigational Site

Tokyo, 113-8431, Japan

Location

GSK Investigational Site

Busan, South Korea

Location

GSK Investigational Site

Daegu, 700-721, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 133-792, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

Related Publications (10)

• Zhang F, Bae SC, Bass D, Chu M, Egginton S, Gordon D, Roth DA, Zheng J, Tanaka Y. 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 Mar;77(3):355-363. doi: 10.1136/annrheumdis-2017-211631. Epub 2018 Jan 2.

  PMID: 29295825 BACKGROUND

• Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.

  PMID: 39115551 DERIVED

• Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.

  PMID: 38216728 DERIVED

• Suh CH, Lee Y, Yoo SB, Quasny H, Navarro Rojas AA, Hammer A, Song YW, Kang YM, Cho CS, Park W, Kwok SK, Lee SG, Chung WT, Bae SC. Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo-controlled trial in North East Asia. Int J Rheum Dis. 2024 Jan;27(1):e14997. doi: 10.1111/1756-185X.14997. Epub 2023 Dec 23.

  PMID: 38140854 DERIVED

• Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.

  PMID: 37228028 DERIVED

• Zhang F, Zheng J, Li Y, Wang G, Wang M, Su Y, Gu J, Li X, Bass D, Chu M, Curtis P, DeRose K, Kurrasch R, Lowe J, Meizlik P, Roth DA. 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 Apr;8(1):e001669. doi: 10.1136/rmdopen-2021-001669.

  PMID: 35428697 DERIVED

• Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

  PMID: 34741731 DERIVED

• Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

  PMID: 34628605 DERIVED

• Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.

  PMID: 34531304 DERIVED

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

  PMID: 33687069 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The primary objective for DB was efficacy and the participant flow is aligned with the MITT population. The primary objective for OL is safety and includes only China par. from DB + additional 25 China par. from the Safety Pop who were not in MITT.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: May 23, 2011
• Primary Completion: September 15, 2015
• Study Completion: September 21, 2018
• Last Updated: October 4, 2019
• Results First Posted: December 2, 2016

Record last verified: 2019-09

Locations

KR (8); CN (23); JP (16)