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An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10

NCT03385564•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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, Poland, Portugal, Serbia, Spain, Taiwan, Thailand, United Kingdom, United States

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (36)

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

Key Dates

Start Date

January 9, 2018

Primary Completion Date

May 25, 2021

Completion Date

July 27, 2021

Last Updated

July 13, 2022

Enrollment

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

BI 655064

DRUG

Placebo

DRUG

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

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RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

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