Status:
COMPLETED
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 therap...
Detailed Description
Initially planned participating countries: Argentina, Australia, Canada, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Malaysia, Mexico, Philippines, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03385564
Start Date
January 9 2018
End Date
July 27 2021
Last Update
July 13 2022
Active Locations (36)
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1
Integral Rheumatology and Immunology Specialist
Plantation, Florida, United States, 33324
2
Northwell Health
Great Neck, New York, United States, 11021
3
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
4
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States, 10032