An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BI 655064; Placebo
Intervention description: subcutaneous injection; subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main objectives of this trial are to evaluate the long term efficacy and safety of
      different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC)
      during maintenance therapy for lupus nephritis.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  Evidence of current or previous clinically significant diseases or medical conditions
             other than lupus, or findings of the medical examination (including vital signs and
             ECG) that, in the opinion of the investigator, would compromise the safety of the
             patient or the quality of the data. This criterion provides an opportunity for the
             investigator to exclude patients based on clinical judgment, even if other eligibility
             criteria are satisfied.

          -  Significant central nervous system symptoms related to Systemic Lupus Erythematosus
             (SLE) based on investigators assessment.

          -  Clinically important acute or chronic infections including but not limited to HIV,
             hepatitis B or C.

          -  Impaired hepatic function defined as serum Aspartate Aminotransferase/Alanine
             Aminotransferase (AST/ALT), bilirubin or alkaline phosphatase > 2 x Upper Limit of
             Normal (ULN).

          -  Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening (using
             CKD-EPI formula).

          -  Known hypersensitivity to any constituents of the trial medication; and/or
             contraindications to Mycophenolate mofetil (MMF) or Azathioprine (AZA) or
             glucocorticoids.

          -  The use of any restricted medications or any drug considered likely to interfere with
             the safe conduct of the trial.

          -  Unable to comply with the protocol in the investigator's opinion.

          -  Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
             makes them an unreliable trial patient or unlikely to complete the trial.

          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial.