Active Lupus Nephritis MedDRA version: 12.1 Level: LLT Classification code 10025140 Term: Lupus nephritis
Conditions
Interventions
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptiv
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects diagnosed with SLE, who fulfilled at least 4 classification criteria of the American College of Rheumatology for SLE by the time of screening visit. 2.Kidney biopsy within 6 months prior to baseline with a histological diagnosis of LN. 3.Clinically active LN 4.Subjects must be between the ages of 18 and 75 years (inclusive). 5.Subjects are willing and able to provide a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.GFR = 30 ml/min/1.73m2 as calculated by MDRD formula at screening visit. 2.Dialysis within the last month prior to screening or scheduled to receive dialysis. 3.Previous kidney transplant or planned transplant. 4.Subjects with hemoglobin 120kg (265 pound). 9. Subjects with a = 2.5x upper limit of normal (ULN) serum elevation of either ALT or AST at screening. 10.Subjects with a = 2x upper limit of normal direct or total bilirubin at screening. 11.Subjects diagnosed with Diabetes Mellitus, or Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Vasculitis. 12.Medical condition, other than SLE that requires chronic treatment with immunosuppressive drugs or systemic corticosteroids (not including inhaled steroids). 13.Subjects with a history of malignancy within 5 years from screening with the exception of basal cell carcinoma (completely excised). 14.Women who are pregnant or nursing at the time of screening, or who intend to be during the study period. 15.Women of child-bearing potential who do not practice an acceptable method of birth control. 16.Subjects treated with MMF dose = 2 g/day anytime between 31 days and 90 days prior to baseline or MMF dose >2 g/day within 30 days prior to baseline. 17.Subjects treated with oral corticosteroids at doses higher than 20 mg/day of prednisolone/prednisone (or equivalent) anytime between 8 and 90 days prior to baseline or prednisolone/prednisone dose (or equivalent) >40 mg/day within 7 days prior to baseline or any IV or IM steroid dose within 90 days prior to baseline. 18.Subjects treated with Azathioprine, MTX, Cyclosporine or Tacrolimus within 2 weeks prior to baseline. 19.Subjects treated with cyclophosphamide within 12 weeks prior to screening. 20.Subjects treated with Rituximab, abatacept, intravenous immune globulin (IV Ig), plasmapheresis or any other biologic therapy within 24 weeks prior to screening. 21.Subjects treated with alkylating agents (other than cyclophosphamide such as: nitrogen mustard, chlorambucil, vincristine, procarbazine or etopside) within 52 weeks prior to screening. 22.Subjects who received any investigational medication within 24 weeks prior to screening. 23.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine). 24.Use of amiodarone within 2 years prior to screening visit. 25.A known drug hypersensitivity that would preclude administration of study medications, such as known hypersensitivity to MMF, corticosteroids or hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate. 26.Subjects unable to comply with the planned schedule of study visits and study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To evaluate the safety and tolerability of two doses of laquinimod (0.5 mg and 1 mg/day), in subjects with active Lupus Nephritis in combination with standard of care (MMF and steroids). ?To evaluate biomarkers and clinical effect of two doses of laquinimod (0.5 mg and 1 mg/day), in subjects with active Lupus Nephritis in combination with standard of care (MMF and steroids). ;Secondary Objective: -;Primary end point(s): This study is exploratory in nature; therefore, no formal statistical hypothesis testing is planned. | — |
Countries
France, United Kingdom
Outcome results
None listed