A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BELIMUMAB (HGS 1006) ADMINISTERED SUBCUTANEOUSLY (SC) TO SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE).

Not Applicable

• Registration Number: PER-046-12
• Lead Sponsor: HUMAN GENOME SCIENCES, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. ARE AT LEAST 18 YEARS OF AGE.
2. HAVE A CLINICAL DIAGNOSIS OFSLE ACCORDING TO THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA. (APPENDIX 1).
3. HAVE ACTIVE SLE DISEASE DEFINED AS A SELENA SLEDAI SCORE ≥ 8 AT SCREENING. (APPENDIX 3). (REFER TO SECTION 6.9.1.1 SCORING FOR PROTEINURIA FOR ELIGIBILITY AND AT SCREENING.)
4. HAVE UNEQUIVOCALLY POSITIVE AUTOANTIBODY TEST RESULTS DEFINED AS AN ANA TITRE ≥ 1:80 AND/OR A POSITIVE ANTI-DSDNA (≥ 30 IU/ML) SERUM ANTIBODY TEST FROM 2 INDEPENDENT TIME POINTS AS FOLLOWS:
• POSITIVE TEST RESULTS FROM 2 INDEPENDENT TIME POINTS WITHIN THE STUDY SCREENING PERIOD. SCREENING RESULTS MUST BE BASED ON THE STUDY´S CENTRAL LABORATORY RESULTS.
OR
• ONE POSITIVE HISTORICAL TEST RESULT AND 1 POSITIVE TEST RESULT DURING THE SCREENING PERIOD.
- HISTORICAL DOCUMENTATION OF A POSITIVE TEST OF ANA (EG, ANA BY HEP-2 TITER)
OR ANTI-DSDNA (EG, ANTI-DSDNA BY FARR ASSAY) MUST INCLUDE THE DATE AND TYPE OF THE TEST, THE NAME OFTHE TESTING LABORATORY, NUMERICAL REFERENCE RANGE, AND A KEY THAT EXPLAINS VALUES PROVIDED AS POSITIVE VS NEGATIVE OR NEGATIVE.
EQUIVOCAL/BORDERLINE POSITIVE).

Exclusion Criteria

1. HAVE RECEIVED TREATMENT WITH ANY B CELL TARGETED THERAPY (EG, RITUXIMAB, OTHER ANTI-CD20 AGENTS, ANTI-CD22 [EPRATUZUMAB], ANTI-CD52 [ALEMTUZUMAB], BLYS-RECEPTOR FUSION PROTEIN [BR3], TACI-FC, ANTI-BAFF (LY2127399) OR ANTI-BLYS [BELIMUMAB]) AT ANY TIME.
2. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 364 DAYS OF DAY O:
• ABATACEPT.
• A BIOLOGIC INVESTIGATIONAL AGENT OTHER THAN B CELL TARGETED THERAPY (EG, ABETIMUS SODIUM, ANTI-CD40L ANTIBODY [BG9588/ IDEC-131 D. (INVESTIGATIONAL AGENT APPLIES TO ANYDRUG NOT APPROVED FOR SALE IN THE COUNTRY IN WHICH IT IS BEING USED.)
3. HAVE REQUIRED 3 OR MORE COURSES OF SYSTEMIC CORTICOSTEROIDS FOR CONCOMITANT CONDITIONS (EG, ASTHMA, ATOPIC DERMATITIS) WITHIN 364 DAYS OFDAY O. (TOPICAL OR INHALED STEROIDS ARE PERMITTED. )
4. HAVE RECEIVED ANY OFTHE FOLLOWING WITHIN 90 DAYS OFDAY O:
• ANTI-TNF THERAPY (EG, ADALIMUMAB, ETANERCEPT, INFLIXIMAB).
• INTRAVENOUS (IV) CYCLOPHOSPHAMIDE.
• INTERLEUKIN-L RECEPTOR ANTAGONIST (ANAKINRA).
• INTRAVENOUS IRNRNUNOGLOBULIN (LVIG).
• HIGH DOSE PREDNISONE OR EQUIVALENT (> 100 RNG/DAY).
• PLASMAPHERESIS.
5. RAVE RECEIVED ANY OFTHE FOLLOWING WITHIN 60 DAYS OF DAY 0:
• A NON-BIOLOGIC INVESTIGATIONAL AGENT.
• ANY NEW IMMUNOSUPPRESSIVE/IMMUNOMODULATORY AGENT, ANTI-MALARIAL, OR NSAID (SEE INCLUSION CRITERION #5).

Study & Design

• Study Type: Interventional
• Study Design: Not specified