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

Phase 2

Completed

Conditions: Lupus Nephritis

Interventions: Drug: BI 655064 dose 1
Drug: BI 655064 dose 2
Drug: BI 655064 dose 3
Drug: Placebo

Registration Number: NCT02770170

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 655064 dose 1	BI 655064 dose 1	-
BI 655064 dose 2	BI 655064 dose 2	-
BI 655064 dose 3	BI 655064 dose 3	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Complete Renal Response (CRR) at Week 52	At week 52.	Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR \< 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min). CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) \<3 or \>=3 g/day). Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Partial Renal Response (PRR) at Week 52	At week 52.	Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
Percentage of Patients With Complete Renal Response (CRR) at Week 26	At week 26.	Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 26 and either estimated glomerular filtration rate (eGFR) within normal range at Week 26 or decrease in eGFR \< 20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
Percentage of Patients With Partial Renal Response (PRR) at Week 26	At week 26.	Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
Percentage of Patients With Major Renal Response (MRR) at Week 26	At week 26.	Major renal response was defined as follows depending on proteinuria at baseline: * If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR) * If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Percentage of Patients With Major Renal Response (MRR) at Week 52	At week 52.	Major renal response was defined as follows depending on proteinuria at baseline: * If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR) * If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)

Trial Locations

Locations (74): Academic Medical Research Institute
🇺🇸
Los Angeles, California, United States
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
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Academic Medical Research Institute
🇺🇸Los Angeles, California, United States