Efficacy and safety of BI 655064 in patients with Lupus Nephritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 209

Inclusion Criteria

males and females 18-70 years. Women of childbearing potential* must be ready and able 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. The reliable contraception should be used before starting MMF therapy and the study drug, during the treatment and until 50 days after stopping MMF and the study drug. Sexually active men must be ready to use condoms during treatment with MMF and for at least 90 days after cessation of MMF treatment.
Diagnosis of systemic lupus erythematosus (SLE) by 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 (ISN/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) at screening
Signed and dated 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 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

clinically significant current other renal disease
GFR<30ml/min/1.73m²
Acute presence of Oliguria (<500 mL/day)
dialysis within 12m of screening
Antiphospholipid syndrom defined as positive antiphospholipid antibodies and either history of any thrombotic event and or history of miscarriage.
diabetes mellitus poorly controlled or known diabethic 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 LN within the last 6 months prior to randomisation except induction with MMF and high dose steroids tarted within 6 weeks prior to randomisation. If a higher dose of iv steroids is considered necessary by the investigator a total dose of up to 3g is acceptable
Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22) within 12 months prior to randomisation
Treatment with Belimumab or other anti BLyS: when used for treatment of non-renal SLE 3 months or 5 half lives whichever is longer, prior to randomisation ; when used for treatment of Lupus nephrits: 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
Live vaccination within 6 weeks before randomisation
Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical 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.
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 AST/ALT, bilirubin or alkaline phosphatase levels > 2 x ULN
Significant central nervous system symptoms related to SLE based on investigator assessment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: assess efficacy and safety of one year treatment with three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis;Secondary Objective: assess the efficacy at 6 months;Primary end point(s): 1: proportion of patients with complete renal response<br>;Timepoint(s) of evaluation of this end point: 1: week 52<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: proportion of patients with complete renal response<br><br>2: proportion of patients with partial renal response<br><br>3: proportion of patients with major renal response<br>;Timepoint(s) of evaluation of this end point: 1: week 26<br><br>2: week 26 and 52<br><br>3: week 26 and 52<br>

Related Trials