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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT03385564

Run by

Boehringer Ingelheim

People needed

69

Starts

2018-01-09

Expected to finish

2021-07-27

Last updated by the study team

2022-07-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Integral Rheumatology and Immunology Specialist — Plantation, Florida, United States
• Northwell Health — Great Neck, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
• Princess Alexandra Hospital — Woolloongabba, Australia
• CHU de Quebec-Universite Laval Research Centre — Québec, Canada
• General University Hospital — Prague, Czechia
• Institute of Rheumathology Prague — Prague, Czechia
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Germany
• Robert-Bosch-Krankenhaus GmbH — Stuttgart, Germany
• University General Hospital Attikon — Athens, Greece
• University General Hospital of Heraklion — Heraklion, Crete, Greece
• Prince of Wales Hospital — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• Hokkaido University Hospital — Hokkaido, Sapporo, Japan
• Tohoku University Hospital — Miyagi, Sendai, Japan
• Okayama University Hospital — Okayama, Okayama, Japan
• Juntendo University Hospital — Tokyo, Bunkyo-ku, Japan
• Hospital Tengku Ampuan Rahimah — Klang, Malaysia
• Centenario Hospital Miguel Hidalgo — Aguascalientes, Mexico
• Instituto Nacional de Cardiologia Ignacio Chavez — Mexico City, Mexico
• Instituto Nacional de Cs Médicas y Nutrición S Zubiran — Mexico City, Mexico
• Southern Philippines Medical Center — Davao City, Philippines
• Mary Mediatrix Medical Center — Lipa City, Batangas, Philippines
• University Clinical Hospital in Bialystok I — Bialystok, Poland

Full record on ClinicalTrials.gov

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