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NCT02770170 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lupus Nephritis, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
121
Enrollment target
20
Study locations

NCT02770170: Completed Phase 2 study of Lupus Nephritis, sponsored by Boehringer Ingelheim.

NCT02770170 is a Phase 2 study of Lupus Nephritis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 121 participants, below the 306-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02770170, a Phase 2 study of Lupus Nephritis, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
121 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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 (A

Conditions Studied

Lupus Nephritis

Interventions

  • DRUG Placebo
  • DRUG BI 655064 dose 1
  • DRUG BI 655064 dose 2
  • DRUG BI 655064 dose 3

Study Locations (20)

Other

  • Princess Alexandra Hospital - Woolloongabba
  • CHU de Quebec-Universite Laval Research Centre - Québec
  • Hospital Hradec Kralove - Hradec Králové
  • General University Hospital Prague 2, Nephrology Clinic - Prague
  • Institute of Rheumathology Prague - Prague
  • HOP Henri Mondor - Créteil
  • HOP La Pitié Salpêtrière - Paris
  • Universitätsklinikum Köln (AöR) - Cologne
  • Universitätsmedizin Göttingen, Georg-August-Universität - Göttingen

Florida

  • Integrity Clinical Research, LLC - Doral
  • Hope Clinical Research - Kissimmee
  • Integral Rheumatology and Immunology Specialist - Plantation

New York

  • Northwell Health - Great Neck
  • Feinstein Institute for Medical Research - Manhasset
  • Columbia University Medical Center-New York Presbyterian Hospital - New York

California

  • Academic Medical Research Institute - Los Angeles

Georgia

  • Emory University - Atlanta

Tennessee

  • Office of Dr. Ramesh C. Gupta - Memphis

New South Wales

  • The Prince of Wales Hospital - Randwick

Ontario

  • Toronto Western Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2016-05-16
Est. Completion 2020-08-18
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT02770170 record still lists

NCT02770170 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 306-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (60% lower).

The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT02770170 names 20 study sites across 8 states, led by Other, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT02770170 about?

NCT02770170 is a clinical study titled "Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis". 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 targe...

What is the current status of trial NCT02770170?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2016-05-16. Estimated completion is 2020-08-18.

What conditions does trial NCT02770170 study?

This clinical trial studies the following conditions: Lupus Nephritis.

What interventions are being tested in trial NCT02770170?

The interventions under investigation include: Placebo (DRUG), BI 655064 dose 1 (DRUG), BI 655064 dose 2 (DRUG), BI 655064 dose 3 (DRUG).

Who is sponsoring clinical trial NCT02770170?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02770170 being conducted?

This trial has 20 study locations across California, Florida, Georgia, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Lupus Nephritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02770170's enrollment target sits among peer trials

121 12th of 30 higher than 19 of 30 other Lupus Nephritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02770170, the US trial registry maintained by the National Library of Medicine. NCT02770170 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.