A CLINICAL STUDY TO ASSESS THE EFFICACY OF ORELVO (VOCLOSPORIN) COMPARED WITH PLACEBO IN ACHIEVING RENAL RESPONSE AFTER 24 WEEKS OF THERAPY IN SUBJECTS WITH ACTIVE LUPUS NEPHRITIS (LN)
- Conditions
- -M321 Systemic lupus erythematosus with organ or system involvementSystemic lupus erythematosus with organ or system involvementM321
- Registration Number
- PER-023-17
- Lead Sponsor
- Aurinia Pharmaceutical Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 19
1.Written informed consent before any study-specific procedures are performed.
2.Male or female subjects with a minimum age of 18 (or legal age of consent if >18 years) to 75 years of age, inclusive, at the time of screening (Visit 1).
3.Previous diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria
4.Subjects with evidence of active nephritis, defined as follows:
Kidney biopsy result within 2 years prior to screening indicating Class III, IV S or IV-G (alone or in combination with Class V) LN with a doubling or greater increase of urine protein creatinine ratio (UPCR) within the last 6 months to a minimum of ≥1.5 mg/mg at screening.
OR
Kidney biopsy result within 6 months prior to screening indicating Class III, IV S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.
OR
Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening.
A biopsy can be performed during screening, if not available. The above criteria must be fulfilled at baseline.
5.In the opinion of the Investigator, subject requires high-dose corticosteroids and immunosuppressive therapy.
6.Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.
7.Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study
1.Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
2.Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/minute/1.73 m2 at screening confirmed before randomization.
3.Currently taking or known need for any of the medications listed in Section 7.8, Prohibited Therapy and Concomitant Treatment at screening or during the study. This includes prohibited medications prior to screening as specified in Section 7.8.1, Prohibited Medications.
4.Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
5.A previous kidney transplant or planned transplant within study treatment period.
6.Any known hypersensitivity or contraindication to MMF, mycophenolic acid, cyclosporine, corticosteroids or any components of these drug products.
7.Current or medical history of:
•Congenital or acquired immunodeficiency.
•In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
•Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed.
•Lymphoproliferative disease or previous total lymphoid irradiation.
•Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) within 3 months of screening; or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
•Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid (see Section 9.2.1, Screening Visit Procedures).
8.Other known clinically significant active medical conditions, such as:
•Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome. QT interval duration corrected for heart rate using method of Fridericia exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at time of screening will result in exclusion.
•Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥2.5 times the upper limit of normal) at screening and, if abnormal at screening, then confirmed that the levels have returned to <2.5 times upper limit of normal before randomization.
•Chronic obstructive pulmonary disease or asthma requiring oral steroids.
•Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 × 103/μL; thrombocytopenia (platelet count <50,000/mm3).
•Active bleeding disorders.
•Current infection requiring IV antibiotics.
9.Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g., Sjögren’s syndrome) are not excluded.
10.No vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method