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
  Purpose

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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Proportion of subjects who achieve renal response (complete or partial) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Background Therapy
Placebo plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: Placebo
Intravenous (IV) Infusion
Experimental: BIIB023 Low Dose + Background Therapy
BIIB023 low dose plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: BIIB023
Intravenous (IV) Infusion of BIIB023 Low Dose
Experimental: BIIB023 High Dose + Background Therapy
BIIB023 high dose plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: BIIB023
Intravenous (IV) Infusion of BIIB023 High Dose

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Biogen Clinical Trials immunologyclinicaltrials@biogenidec.com

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Locations
United States, California
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La Jolla, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Torrance, California, United States
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Washington, District of Columbia, United States
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Orlando, Florida, United States
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Zrenjanin, Serbia
South Africa
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Sagunto, Valencia, Spain
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Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01499355     History of Changes
Other Study ID Numbers: 211LE201, EUDRA CT NO: 2011-002159-32
Study First Received: November 23, 2011
Last Updated: January 24, 2014
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Agency for the Safety of drug and health products
Australia: Therapeutic Goods Administration (TGA)
Spain: Spanish Agency for Medicines and Health Products
Malaysia: National Pharmaceutical Control Bureau
Hong Kong: Department of Health
Peru: Instituto Nacional de Salud (INS)
Mexico: Comisión Federal para la Protección contra riesgos sanitarios (COFEPRIS)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Serbia: Medicines and Medical Devices Agency of Serbia
South Africa: MCC - Medicines Control Council
Thailand: Ministry of Pulbic Health
Hungary: National Institute of Pharmacy
Canada: Health Canada
South Korea: Food and Drug Administration
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation
Italy: Italian Medicines Agency

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 July 29, 2014