A study is to find out whether a new oral drug, laquinimod, given inaddition to the standard/routine treatment is safe and may improvelupus nephritis disease response to treatment.
- Conditions
- Active Lupus NephritisMedDRA version: 13.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-018329-20-GB
- Lead Sponsor
- Teva Pharmaceutical Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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 12 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
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 < 8.5 g/dl or neutrophils < 1300/ mm3 or platelets < 50,000/mm3 at screening.
5.Any previous diagnosis of drug induced lupus.
6.Subjects with severe, unstable and/or progressive CNS lupus and/or associated with significant cognitive impairment.
7.Subjects with a clinically significant or unstable medical or surgical condition that, in the Investigator’s opinion, would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests or imaging.
8.MMF/steroids specific exclusion criteria:
Pancreatitis within 6 months prior to screening.
Gastrointestinal hemorrhage within 6 months prior to screening.
Peptic ulcers (unhealed) within 3 months prior to screening
Subject weight > 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.Subjects treated with sevelamer, acyclovir, valacyclovir, ganciclovir,
rifampin, antacids that contain magnesium and aluminium hydroxide,
norfloxacin, metronidazole or cholestyramine at screening or baseline.
26.A known drug hypersensitivity that would preclude administration of study medications, such as known hypersensitivity to MMF, corticosteroids or hypersensitivity to: mannitol, megl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br>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).<br>;Secondary Objective: -;Primary end point(s): This study is exploratory in nature; therefore, no formal statistical hypothesis testing is planned.<br>;Timepoint(s) of evaluation of this end point: All study outcome measures will be evaluated at week 24.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA