Clinical trial NCT01930890: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 87
Sex: ALL
Minimum age (years): 19
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 108
measure: Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
timeFrame: Up to Week 108
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: El Paso
country: United States
facility: Research Site
state: Texas
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Research Site
city: San Juan
country: Argentina
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Cuiabá
country: Brazil
facility: Research Site
state: Mato Grosso
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Medellín
country: Colombia
facility: Research Site
city: Pessac
country: France
facility: Research Site
state: Gironde
city: Paris
country: France
facility: Research Site
state: Paris cedex 13
city: Shatin
country: Hong Kong
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Kuching
country: Malaysia
facility: Research Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Cuauhtemoc
country: Mexico
facility: Research Site
state: Distrito Federal
city: Lima
country: Peru
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Sagunto
country: Spain
facility: Research Site
state: Valencia
city: Bangkoknoi
country: Thailand
facility: Research Site
state: Bangkok
city: Pathumwan
country: Thailand
facility: Research Site
state: Bangkok
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: