BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis (ATLAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 18, 2014
Last verified: August 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 participants 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. Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).


Condition Intervention Phase
Lupus Nephritis
Biological: BIIB023
Biological: Placebo
Drug: Mycophenolate Mofetil
Drug: Oral corticosteroid regimen
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:
  • Percentage of participants who achieve a complete or partial renal response at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Complete renal response is defined as urinary protein:creatinine ratio (uPCR) <0.5 mg/mg with ≥50% reduction of uPCR from Baseline (from a 24-hour urine collection) and estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as ≥50% reduction in uPCR from Baseline with one of the following: a) uPCR of <1.0 mg/mg if the Baseline was ≤ 3.0 mg/mg, or b) uPCR <3.0 mg/mg if the Baseline ratio was >3.0 mg/mg; and stabilization of renal function (eGFR ± 25% of Baseline or serum creatinine within normal range).


Secondary Outcome Measures:
  • Percentage of participants who achieve complete renal response at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Complete renal response is defined as urinary protein:creatinine ratio (uPCR) <0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and estimated glomerular filtration rate (eGFR) within normal range.

  • Duration of response in participants who achieve complete renal response at week 52 [ Time Frame: Up to Week 64 ] [ Designated as safety issue: No ]
  • Percentage of participants uPCR >3.0 mg/mg at Baseline who achieve uPCR <1.0 mg/mg [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to renal response (partial or complete) in participants who achieve renal response [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of participants with active urinary sediment at Baseline who have inactive urinary sediment at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): • > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory • Presence of cellular casts (RBC or WBC) Inactive urinary sediment defined as: • < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and • no cellular casts (no RBC or WBC casts)

  • Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to study discontinuation [ Time Frame: Up to Week 56 ] [ Designated as safety issue: Yes ]
  • Duration of renal response [ Time Frame: Up to week 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 211
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 intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: Placebo
Intravenous (IV) Infusion
Drug: Mycophenolate Mofetil
Mycophenolate mofetil titrated to a target daily dose of 2 g (1 g twice daily)
Drug: Oral corticosteroid regimen
Oral corticosteroid regimen (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Experimental: BIIB023 3 mg/kg
BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: BIIB023
Intravenous (IV) Infusion of BIIB023
Drug: Mycophenolate Mofetil
Mycophenolate mofetil titrated to a target daily dose of 2 g (1 g twice daily)
Drug: Oral corticosteroid regimen
Oral corticosteroid regimen (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Experimental: BIIB023 20 mg/kg
BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and Mycophenolate Mofetil (MMF)
Biological: BIIB023
Intravenous (IV) Infusion of BIIB023
Drug: Mycophenolate Mofetil
Mycophenolate mofetil titrated to a target daily dose of 2 g (1 g twice daily)
Drug: Oral corticosteroid regimen
Oral corticosteroid regimen (prednisone or equivalent) at a target prednisone dose of 10 mg/day

  Eligibility

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

Key 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.

Key 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 glomerular filtration rate (GFR) <30 mL/min per 1.73 m^2 (calculated using the abbreviated Modification of Diet in Renal Disease [MDRD] equation) or the presence of oliguria or end-stage renal disease [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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  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 Idec clinicaltrials@biogenidec.com

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Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
Investigators
Study Director: Medical Director Biogen Idec
  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: August 18, 2014
Health Authority: Israel: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Malaysia: National Pharmaceutical Control Bureau
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hong Kong: Department of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Serbia: Medicines and Medical Devices Agency of Serbia
Thailand: Ministry of Public Health
Spain: Spanish Agency of Medicines
Mexico: Federal Commission for Sanitary Risks Protection
Portugal: National Pharmacy and Medicines Institute
Colombia: National Institutes of Health
South Africa: Medicines Control Council
Malaysia: Ministry of Health
Thailand: Food and Drug Administration
Peru: Instituto Nacional de Salud
Hungary: National Institute of Pharmacy
Canada: Health Canada
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Turkey: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation
Italy: The 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
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014