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

November 23, 2011
August 18, 2014
July 2012
September 2016   (final data collection date for primary outcome measure)
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).
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
  • 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 ]
  • 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
 
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
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 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).

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
  • 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
  • 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)
    Interventions:
    • Biological: Placebo
    • Drug: Mycophenolate Mofetil
    • Drug: Oral corticosteroid regimen
  • 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)
    Interventions:
    • Biological: BIIB023
    • Drug: Mycophenolate Mofetil
    • Drug: Oral corticosteroid regimen
  • 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)
    Interventions:
    • Biological: BIIB023
    • Drug: Mycophenolate Mofetil
    • Drug: Oral corticosteroid regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
211
December 2016
September 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
Belgium,   United States,   Argentina,   Australia,   Turkey,   Brazil,   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
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

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