Anti-TWEAK in lupus nephritis study
- Conditions
- upus NephritisMedDRA version: 14.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-002159-32-HU
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
•Aged 18 to 75 years old, inclusive, at the time of informed consent.
•Must have a documented diagnosis of SLE according to current ACR criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-dsDNA antibody.
•Must have a diagnosis of ISN/RPS 2003 Class III or IV LN with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Subjects are permitted to have co-existing Class V LN. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
•Must have proteinuria at Screening (from a 24-hour urine sample collection) defined as: uPCR >1.0 mg/mg
•Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
•Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
•Estimated GFR <30 mL/min per 1.73 m2 (calculated using the abbreviated MDRD equation) or the presence of oliguria or ESRD requiring dialysis or transplantation
•Subjects requiring dialysis within 12 months prior to Screening
•History of renal transplant
•History of opportunistic infection within 3 years of Screening.
•Subjects with the following abnormal laboratory test result at Screening considered clinically significant (as determined by the Investigator) or: AST/SGOT or ALT/SGPT >2 x upper limit of normal established by the central laboratory; platelet count <20,000/µL; subjects with platelet count >20,000/µL and <150,000 who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator) should be excluded from the study; hemoglobin <8.5 g/dL; neutrophils <1.5 x 103/µL
•Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of subjects with active, biopsy-proven LN.;Secondary Objective: Secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.;Primary end point(s): Proportion of subjects who achieve a renal response (complete or partial renal response) at Week 52. <br><br>;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method