Clinical trial NCT01499355: BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability 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: 2011-12-26
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

Detailed description: Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).

Eligibility criteria: Key Inclusion Criteria:

* Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
* Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
* Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) \>1.0 mg/mg.

Key Exclusion Criteria:

* Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
* Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
* Subjects requiring dialysis within 12 months prior to Screening
* History of renal transplant
* Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 \[rituximab\], anti-CD22 \[epratuzumab\], anti-BLyS/B-cell activating factor \[e.g., briobacept, belimumab\] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieve Complete Renal Response at Week 52
timeFrame: Week 52
measure: Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52
timeFrame: Week 52
measure: Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52
timeFrame: Baseline (Day 1), Week 52
measure: Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52
timeFrame: Baseline, Week 52
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period
timeFrame: Day 1 to Week 12
measure: Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period
timeFrame: Week 12 to Week 56
measure: Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study
timeFrame: up to Week 52
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Research Site
state: California
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
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: Capital Federal
country: Argentina
facility: Research Site
state: Ciudad Autonoma Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: San Juan
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Cuiaba
country: Brazil
facility: Research Site
state: Mato Grosso
city: Sao Paulo
country: Brazil
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Medelin
country: Colombia
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
state: Gironde
city: Lille
country: France
facility: Research Site
state: Nord
city: Paris 9
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
state: Sarawak
city: Ipoh
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Pulau Pinang
country: Malaysia
facility: Research Site
city: Selangor Darul Ehsan
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Saltillo
country: Mexico
facility: Research Site
state: Coahuila
city: Cuauhtemoc
country: Mexico
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
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: Wroclaw
country: Poland
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Sagunto
country: Spain
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
state: Bangkok
city: Patumwan
country: Thailand
facility: Research Site
state: Bangkok
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: