An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

Inclusion Criteria

• •Male or female patients.
• •Women of childbearing potential and men able to father a child must be ready and able to use two reliable methods of birth control simultaneously, one of which must be highly effective. Highly effective birth control per International Conference on Harmonisation (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 methods of birth control must be used before starting Mycophenolate mofetil/Azathioprine (MMF/AZA) and the trial drug; then continue during the trial period; and for at least 50 days after the last dose of MMF/AZA and trial medication. In case a female patient is treated with AZA the contraception shall continue for 90 days after treatment with AZA.A list of contraception methods meeting these criteria is provided in the patient information.
• •Sexually active men must be ready to use condoms during treatment with MMF/AZA and for at least 90 days after cessation of MMF/AZA.
• •Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy.
• •Tubal ligation is NOT a method of permanent sterilisation.
• •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• •For Group 1 patients only:
• •\- Achieved either a Complete renal Response (CRR) or a Partial Renal Response (PRR) or proteinuria ≤ 1g/d (or UP/UC ≤ 1) at the end of 1293.10.