BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

November 22, 2016 updated by: Biogen

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

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
        • Research Site
      • San Juan, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Research Site
  • Belgium
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
  • Brazil
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78040-360
        • Research Site
  • Colombia
      • Barranquilla, Colombia
        • Research Site
      • Bogota, Colombia
        • Research Site
      • Medellín, Colombia
        • Research Site
  • France
    • Gironde
      • Pessac, Gironde, France, 33604
        • Research Site
    • Paris cedex 13
      • Paris, Paris cedex 13, France, 75651
        • Research Site
  • Hong Kong
      • Shatin, Hong Kong
        • Research Site
  • Hungary
      • Debrecen, Hungary, 4032
        • Research Site
  • Italy
      • Pisa, Italy, 56126
        • Research Site
  • Korea, Republic of
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Selangor, Malaysia, 41200
        • Research Site
      • Selangor, Malaysia, 43000
        • Research Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Research Site
  • Mexico
    • Distrito Federal
      • Cuauhtemoc, Distrito Federal, Mexico, 06090
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
  • Philippines
      • Manila, Philippines, 1008
        • Research Site
      • Quezon City, Philippines, 1102
        • Research Site
  • Poland
      • Lodz, Poland, 90-153
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 123182
        • Research Site
  • Spain
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Research Site
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Research Site
      • Pathumwan, Bangkok, Thailand, 10330
        • Research Site
  • United States
    • New York
      • Lake Success, New York, United States, 11020
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79905
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • MMF, Cellcept
Drug: oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 108
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.
Up to Week 108

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211LE202
  • 2013-000594-69 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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