Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006363

Trial Description

start of 1:1-Block title

Title

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ATLAS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006363
  •   2014/09/08
  •   2011/11/23
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-002159-32 
  •   NCT01499355  (ClinicalTrials.gov)
  •   211LE201  (Biogen Idec)
  •   EUDRA CT NO: 2011-002159-32 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Lupus Nephritis
  •   M32.1 -  Systemic lupus erythematosus with organ or system involvement
  •   N08.5 -  Glomerular disorders in systemic connective tissue disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Biological: BIIB023
  •   Biological: Placebo
  •   Drug: Mycophenolate Mofetil
  •   Drug: Oral corticosteroid regimen
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Percentage of participants who achieve a complete or partial renal response at Week 52; time frame: Baseline and Week 52; 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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Percentage of participants who achieve complete renal response at Week 52; time frame: Baseline and Week 52; 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
- Percentage of participants uPCR >3.0 mg/mg at Baseline who achieve uPCR <1.0 mg/mg; time frame: Week 52
- Time to renal response (partial or complete) in participants who achieve renal response; time frame: Baseline to Week 52
- Percentage of participants with active urinary sediment at Baseline who have inactive urinary sediment at Week 52; time frame: Week 52; 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
- Duration of renal response; time frame: Up to week 64

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   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
  •   Turkey
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2012/07/31
  •   211
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Biogen
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Biogen
    • Medical Director 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Biogen Idec 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   61
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.