Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BI 655064 dose 1; BI 655064 dose 2; BI 655064 dose 3; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The overall purpose of the study is to assess the efficacy of three different doses of BI
      655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus
      nephritis in order to characterize the dose-response relationship within the therapeutic
      range, and select the target dose for phase III development.
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females 18-70 years. Women of childbearing potential must be ready and able
             (as assessed by investigator) to use simultaneously two reliable methods of birth
             control, one of which must be highly effective. Highly effective method, per ICH
             M3(R2) is a method that result in a low failure rate of less than 1% per year when
             used consistently and correctly.

          -  Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology
             (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a
             positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or
             around time of start of induction therapy

          -  Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal
             Pathology Society (RPS) -2003 classification) with either active or active/chronic
             disease, co-existing class V permitted, proven by renal biopsy within 3 months prior
             to screening or during screening if induction therapy has not yet been started

          -  Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]

          -  Signed and dated written informed consent

        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

          -  Further exclusion criteria apply.