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

This study has been terminated.
(Results from pre-specified criteria did not demonstrate sufficient efficacy to warrant continuation of the study.)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01499355
First received: November 23, 2011
Last updated: November 22, 2016
Last verified: November 2016
Results First Received: November 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Lupus Nephritis
Interventions: Biological: BIIB023
Biological: Placebo
Drug: mycophenolate mofetil
Drug: oral corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 276 participants were enrolled and 203 completed the run-in period and qualified for randomization; of these, 15 participants were not randomized.

Reporting Groups
  Description
Run-In Period: All Enrolled Participants At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
Double-Blind Period: 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 of oral steroids (prednisone or equivalent) and MMF.
Double-Blind Period: 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 of oral steroids (prednisone or equivalent) and MMF.
Double-Blind Period: 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 of oral steroids (prednisone or equivalent) and MMF.

Participant Flow for 2 periods

Period 1:   Run-In Period
    Run-In Period: All Enrolled Participants   Double-Blind Period: Placebo   Double-Blind Period: BIIB023 3 mg/kg   Double-Blind Period: BIIB023 20 mg/kg
STARTED   276   0   0   0 
COMPLETED   245   0   0   0 
NOT COMPLETED   31   0   0   0 
Study Termination                15                0                0                0 
Not Specified                3                0                0                0 
Death                2                0                0                0 
Investigator Decision                2                0                0                0 
Consent Withdrawn                1                0                0                0 
Adverse Event                8                0                0                0 

Period 2:   Double-Blind Period
    Run-In Period: All Enrolled Participants   Double-Blind Period: Placebo   Double-Blind Period: BIIB023 3 mg/kg   Double-Blind Period: BIIB023 20 mg/kg
STARTED   0   63   63   62 
COMPLETED   0   40   38   39 
NOT COMPLETED   0   23   25   23 
Adverse Event                0                2                3                2 
Study Termination                0                18                16                14 
Not Specified                0                1                2                2 
Death                0                1                0                0 
Investigator Decision                0                0                3                3 
Consent Withdrawn                0                0                1                2 
Lost to Follow-up                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Enrolled Participants At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.

Baseline Measures
   All Enrolled Participants 
Overall Participants Analyzed 
[Units: Participants]
 276 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.3  (10.11) 
Gender 
[Units: Participants]
Count of Participants
 
Female      242  87.7% 
Male      34  12.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Percentage of Participants Who Achieve Complete Renal Response at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52   [ Time Frame: Baseline to Week 52 ]

5.  Secondary:   Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52   [ Time Frame: Baseline (Day 1), Week 52 ]

6.  Secondary:   Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52   [ Time Frame: Baseline, Week 52 ]

7.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period   [ Time Frame: Day 1 to Week 12 ]

8.  Secondary:   Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period   [ Time Frame: Week 12 to Week 56 ]

9.  Secondary:   Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study   [ Time Frame: up to Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated based on the review of results following the prespecified, blinded futility analysis, which did not demonstrate sufficient efficacy to warrant continuation of the study. Study was not terminated based on safety considerations.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com



Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01499355     History of Changes
Other Study ID Numbers: 211LE201
2011-002159-32 ( EudraCT Number )
Study First Received: November 23, 2011
Results First Received: November 22, 2016
Last Updated: November 22, 2016