Anti-Tweak in Lupus Nephritis Patients (ATLAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Biogen Idec
Sponsor:
Collaborator:
Biogen Idec Australia Pty Ltd
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01499355
First received: November 23, 2011
Last updated: January 24, 2014
Last verified: January 2014

November 23, 2011
January 24, 2014
July 2012
September 2016   (final data collection date for primary outcome measure)
Proportion of subjects who achieve renal response (complete or partial) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Proportion of subjects with complete and partial renal response [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01499355 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who achieve complete renal response. [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Duration of response in subjects who achieve complete renal response [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with urinary Protein:Creatinine Ratio (uPCR) >3.0 mg/mg at Day 1 (Baseline) who achieve uPCR <1.0 mg/mg [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Time to renal response (partial or complete) in subjects who achieve renal response [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with active urinary sediment at Day 1 (Baseline) who have inactive urinary sediment [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Number of subjects that experience Adverse Events (AEs), and Serious Adverse Events (SAEs) and Adverse Events leading to study discontinuation [ Time Frame: Up to Week 64 ] [ Designated as safety issue: Yes ]
  • Duration of renal response [ Time Frame: Up to week 64 ] [ Designated as safety issue: Yes ]
  • Assess the safety and tolerability of BIIB023 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study. [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Change in SELENA-SLEDAI and BILAG scores from baseline to week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Anti-Tweak in Lupus Nephritis Patients
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

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 Lupus Nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population. Subjects who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol (211LE202).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lupus Nephritis
  • Biological: BIIB023
    Intravenous (IV) Infusion of BIIB023 Low Dose
  • Biological: BIIB023
    Intravenous (IV) Infusion of BIIB023 High Dose
  • Biological: Placebo
    Intravenous (IV) Infusion
  • Placebo Comparator: Placebo + Background Therapy
    Placebo plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
    Intervention: Biological: Placebo
  • Experimental: BIIB023 Low Dose + Background Therapy
    BIIB023 low dose plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
    Intervention: Biological: BIIB023
  • Experimental: BIIB023 High Dose + Background Therapy
    BIIB023 high dose plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
    Intervention: Biological: BIIB023
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented diagnosis of Systemic Lupus Erythematosus (SLE) according to current American College of Rheumatology (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.
  • Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis 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 Lupus Nephritis. 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 urinary Protein:Creatinine Ratio (uPCR) >1.0 mg/mg.

Exclusion Criteria:

  • 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
  • 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.
Both
18 Years to 75 Years
No
Contact: Biogen Clinical Trials immunologyclinicaltrials@biogenidec.com
United States,   Argentina,   Australia,   Belgium,   Canada,   Colombia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Russian Federation,   Serbia,   South Africa,   Spain,   Thailand
 
NCT01499355
211LE201, EUDRA CT NO: 2011-002159-32
Yes
Biogen Idec
Biogen Idec
Biogen Idec Australia Pty Ltd
Not Provided
Biogen Idec
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP