Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Key facts

Study ID

NCT02770170

Run by

Boehringer Ingelheim

People needed

121

Starts

2016-05-16

Expected to finish

2020-08-18

Last updated by the study team

2025-10-16

Who can join

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

You may qualify if…

• Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
• Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
• Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
• Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]
• Signed and dated written informed consent

You may not qualify if…

• Clinically significant current other renal disease
• Glomerular Filtration Rate <30ml/min/1.73m²
• Dialysis within 12m of screening
• Antiphospholipid syndrome
• Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
• Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
• Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation
• Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
• Treatment with abatacept within 12 months prior to randomisation
• Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
• Treatment with cyclophosphamid within 6 months prior to randomisation
• Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
• Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
• Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
• Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
• Live vaccination within 6 weeks before randomisation
• Patients unable to comply with the protocol in the investigator's opinion.
• Alcohol abuse in the opinion of the investigator or active drug abuse .
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal
• Further exclusion criteria apply.

Where it is running

• Integrity Clinical Research, LLC — Doral, Florida, United States
• Hope Clinical Research — Kissimmee, Florida, United States
• Integral Rheumatology and Immunology Specialist — Plantation, Florida, United States
• Emory University — Atlanta, Georgia, 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
• Office of Dr. Ramesh C. Gupta — Memphis, Tennessee, United States
• The Prince of Wales Hospital — Randwick, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Australia
• Toronto Western Hospital — Toronto, Ontario, Canada
• CHU de Quebec-Universite Laval Research Centre — Québec, Canada
• Hospital Hradec Kralove — Hradec Králové, Czechia
• General University Hospital Prague 2, Nephrology Clinic — Prague, Czechia
• Institute of Rheumathology Prague — Prague, Czechia
• HOP Henri Mondor — Créteil, France
• HOP La Pitié Salpêtrière — Paris, France
• Universitätsklinikum Köln (AöR) — Cologne, Germany
• Universitätsmedizin Göttingen, Georg-August-Universität — Göttingen, Germany
• Asklepios Klinik Altona — Hamburg, Germany
• Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, Germany
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Germany
• Robert-Bosch-Krankenhaus GmbH — Stuttgart, Germany
• General Hospital of Athens "Laiko" — Athens, Greece
• Academic Medical Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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