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About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
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
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.
Primary purpose
Allocation
Interventional model
Masking
121 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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