Back to resultsBIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB023
mycophenolate mofetil
oral corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Key Inclusion Criteria:
- Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.
Key Exclusion Criteria:
- Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects' participation. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
- Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
- Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
- Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment.
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BIIB023 3 mg/kg
BIIB023 20 mg/kg
Arm Description
Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF).
Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01930890
Brief Title
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Official Title
A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects With Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).
Detailed Description
This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 will be followed for up to 108 weeks.
Participants who received BIIB023 low dose or high dose in 211LE201 will continue to receive the same dosing in this study (211LE202; NCT01930890) in addition to background therapy. Participants who received placebo in 211LE201 are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIIB023 3 mg/kg
Arm Type
Experimental
Arm Description
Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF).
Arm Title
BIIB023 20 mg/kg
Arm Type
Experimental
Arm Description
Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
Intervention Type
Biological
Intervention Name(s)
BIIB023
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Other Intervention Name(s)
MMF, Cellcept
Intervention Description
titrated to a target daily dose of 2 g (1 g twice daily)
Intervention Type
Drug
Intervention Name(s)
oral corticosteroids
Intervention Description
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Time Frame
Up to Week 108
Title
Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Description
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Time Frame
Up to Week 108
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment.
Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.
Key Exclusion Criteria:
Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects' participation. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment.
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11020
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Research Site
City
San Miguel de Tucuman
State/Province
Tucuman
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
Research Site
City
San Juan
Country
Argentina
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Cuiabá
State/Province
Mato Grosso
ZIP/Postal Code
78040-360
Country
Brazil
Facility Name
Research Site
City
Barranquilla
Country
Colombia
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Medellín
Country
Colombia
Facility Name
Research Site
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Paris
State/Province
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Shatin
Country
Hong Kong
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Research Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Research Site
City
Selangor
ZIP/Postal Code
41200
Country
Malaysia
Facility Name
Research Site
City
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Research Site
City
Cuauhtemoc
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research Site
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Research Site
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
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