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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01499355




Registration number
NCT01499355
Ethics application status
Date submitted
23/11/2011
Date registered
26/12/2011
Date last updated
18/01/2017

Titles & IDs
Public title
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
Secondary ID [1] 0 0
2011-002159-32
Secondary ID [2] 0 0
211LE201
Universal Trial Number (UTN)
Trial acronym
ATLAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BIIB023
Other interventions - Placebo
Treatment: Drugs - mycophenolate mofetil
Treatment: Drugs - oral corticosteroids

Placebo Comparator: Placebo - 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)

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 MMF.

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 MMF.


Other interventions: BIIB023


Other interventions: Placebo


Treatment: Drugs: mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)

Treatment: Drugs: oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve Complete Renal Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52
Timepoint [4] 0 0
Baseline (Day 1), Week 52
Secondary outcome [5] 0 0
Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period
Timepoint [6] 0 0
Day 1 to Week 12
Secondary outcome [7] 0 0
Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period
Timepoint [7] 0 0
Week 12 to Week 56
Secondary outcome [8] 0 0
Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study
Timepoint [8] 0 0
up to Week 52

Eligibility
Key inclusion criteria
Key

- 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. Participants 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 (eGFR) <30 mL/min per 1.73 m^2 (calculated using
the abbreviated Modification of Diet in Renal Disease equation) or the presence of
oliguria or end-stage renal disease 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/B-cell activating factor [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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Tennessee
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United States of America
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Texas
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Tucuman
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Argentina
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Cordoba
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Argentina
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La Plata
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Argentina
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San Juan
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Mato Grosso
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Brazil
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Sao Paulo
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Medelin
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France
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Gironde
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France
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Nord
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France
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Paris 9
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France
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Paris
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Germany
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Mainz
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Hungary
State/province [29] 0 0
Budapest
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Hungary
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Debrecen
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Italy
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Pisa
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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Malaysia
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Sarawak
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Malaysia
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Ipoh
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Malaysia
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Selangor Darul Ehsan
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Malaysia
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Selangor
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Mexico
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Coahuila
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Mexico
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Cuauhtemoc
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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San Luis Potosi
Country [45] 0 0
Peru
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Lima
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Lodz
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Poland
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Wroclaw
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Portugal
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Coimbra
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Spain
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Sagunto
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Thailand
State/province [54] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01499355
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01499355