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ATLAS - Anti-Tweak in Lupus Nephritis Patients

This study is currently recruiting participants.
Verified April 2013 by Biogen Idec
Sponsor:
Collaborators:
Biogen Idec Australia Pty Ltd
Biogen Idec Research Ltd.
Biogen Idec MA Inc.
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01499355
First received: November 23, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

Phase II study designed to evaluate the efficacy, safety, and tolerability of BIIB023 in Subjects With Lupus Nephritis.


Condition Intervention Phase
Lupus Nephritis
 Drug: BIIB023
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Proportion of subjects with complete and partial renal response [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Background Therapy
Background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
 Drug: Placebo
IV Infusion
Experimental: BIIB023 Low Dose + Background Therapy
Background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
 Drug: BIIB023
IV Infusion
Experimental: BIIB023 High Dose + Background Therapy
Background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
 Drug: BIIB023
IV Infusion

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

  • Must have proteinuria at Screening defined as:

    • uPCR >1.0 in subjects with biopsy Class III or IV LN
    • uPCR >2.0 in subjects with co existing Class V LN

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499355

Contacts
Contact: Biogen Clinical Trials immunologyclinicaltrials@biogenidec.com

  Show 101 Study Locations
Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
Biogen Idec Research Ltd.
Biogen Idec MA Inc.
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01499355     History of Changes
Other Study ID Numbers: 211LE201
Study First Received: November 23, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
 Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013