NCT01930890 - BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis | Crick

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

87

Conditions

Lupus Nephritis

Interventions

BIIB023BIOLOGICAL

mycophenolate mofetilDRUG

titrated to a target daily dose of 2 g (1 g twice daily)

oral corticosteroidsDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Locations (33)

Outcomes

Primary Outcomes

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.

Time frame: Up to Week 108

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.

Time frame: Up to Week 108