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BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01930890
Recruitment Status : Terminated (Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study)
First Posted : August 29, 2013
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Biological: BIIB023 Drug: mycophenolate mofetil Drug: oral corticosteroids Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BIIB023 3 mg/kg
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).
 Biological: BIIB023
Drug: mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
Other Name: MMF, Cellcept

Drug: oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Experimental: BIIB023 20 mg/kg
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.
 Biological: BIIB023
Drug: mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
Other Name: MMF, Cellcept

Drug: oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 108 ]
    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.

  2. Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE [ Time Frame: Up to Week 108 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930890


Locations
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United States, New York
Research Site
Lake Success, New York, United States, 11020
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
El Paso, Texas, United States, 79905
Argentina
Research Site
San Miguel de Tucuman, Tucuman, Argentina
Research Site
Ciudad Autonoma Buenos Aires, Argentina
Research Site
San Juan, Argentina
Australia, Victoria
Research Site
Melbourne, Victoria, Australia, 3052
Belgium
Research Site
Leuven, Belgium, 3000
Research Site
Liège, Belgium, 4000
Brazil
Research Site
Cuiabá, Mato Grosso, Brazil, 78040-360
Colombia
Research Site
Barranquilla, Colombia
Research Site
Bogota, Colombia
Research Site
Medellín, Colombia
France
Research Site
Pessac, Gironde, France, 33604
Research Site
Paris, Paris cedex 13, France, 75651
Hong Kong
Research Site
Shatin, Hong Kong
Hungary
Research Site
Debrecen, Hungary, 4032
Italy
Research Site
Pisa, Italy, 56126
Korea, Republic of
Research Site
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
Malaysia
Research Site
Kuching, Sarawak, Malaysia, 93586
Research Site
Kuala Lumpur, Malaysia, 59100
Research Site
Selangor, Malaysia, 41200
Research Site
Selangor, Malaysia, 43000
Mexico
Research Site
Cuauhtemoc, Distrito Federal, Mexico, 06090
Peru
Research Site
Lima, Peru
Philippines
Research Site
Manila, Philippines, 1008
Research Site
Quezon City, Philippines, 1102
Poland
Research Site
Lodz, Poland, 90-153
Russian Federation
Research Site
Moscow, Russian Federation, 123182
Spain
Research Site
Sagunto, Valencia, Spain, 46520
Thailand
Research Site
Bangkoknoi, Bangkok, Thailand, 10700
Research Site
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01930890    
Other Study ID Numbers: 211LE202
2013-000594-69 ( EudraCT Number )
First Posted: August 29, 2013    Key Record Dates
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action