Clinical trial NCT01085097: A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Nephritis
Keywords: Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Laquinimod
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 46
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 study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with SLE
* Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis (LN)
* Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between screening and baseline.

Exclusion Criteria:

* Participants with severe renal impairment or dialysis
* Participants with a clinically significant or unstable medical or surgical condition
* Women who are pregnant or nursing or who intend to be during the study period
* Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 28
measure: Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 1032
state: Arizona
city: La Jolla
country: United States
facility: Teva Investigational Site 1024
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 1028
state: California
city: San Leandro
country: United States
facility: Teva Investigational Site 1025
state: California
city: Baltimore
country: United States
facility: Teva Investigational Site 1031
state: Maryland
city: Rochester
country: United States
facility: Teva Investigational Site 1021
state: Minnesota
city: Lake Success
country: United States
facility: Teva Investigational Site 1022
state: New York
city: Manhasset
country: United States
facility: Teva Investigational Site 1018
state: New York
city: New York
country: United States
facility: Teva Investigational Site 1019
state: New York
city: New York
country: United States
facility: Teva Investigational Site 1017
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 1020
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 1016
state: Ohio
city: Charleston
country: United States
facility: Teva Investigational Site 1030
state: South Carolina
city: Chattanooga
country: United States
facility: Teva Investigational Site 1026
state: Tennessee
city: Edmonton
country: Canada
facility: Teva Investigational Site 1115
state: Alberta
city: Winnipeg
country: Canada
facility: Teva Investigational Site 1114
state: Manitoba
city: Toronto
country: Canada
facility: Teva Investigational Site 1113
state: Ontario
city: Lille
country: France
facility: Teva Investigational Site 3510
city: Paris
country: France
facility: Teva Investigational Site 3509
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 5006
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 5007
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5001
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5003
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 5002
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 5005
city: Birmingham
country: United Kingdom
facility: Teva Investigational Site 3413
city: Cambridge
country: United Kingdom
facility: Teva Investigational Site 3409
city: Dudley
country: United Kingdom
facility: Teva Investigational Site 3412
city: London
country: United Kingdom
facility: Teva Investigational Site 3410
city: Manchester
country: United Kingdom
facility: Teva Investigational Site 3411
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, M.D.
role: STUDY_DIRECTOR
References: