Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Exclusion Criteria

• •Clinically significant current other renal disease
• •Glomerular Filtration Rate \<30ml/min/1.73m²
• •Dialysis within 12m of screening
• •Antiphospholipid syndrome
• •Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
• •Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
• •Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation
• •* Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
• •* Treatment with abatacept within 12 months prior to randomisation
• •* Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
• •* Treatment with cyclophosphamid within 6 months prior to randomisation
• •* Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
• •Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
• •Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
• •Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
• •Live vaccination within 6 weeks before randomisation
• •Patients unable to comply with the protocol in the investigator's opinion.
• •Alcohol abuse in the opinion of the investigator or active drug abuse .
• •Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• •Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels \> 2 x Upper Limit of Normal