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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 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.

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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.

Conditions Studied

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

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT02770170

The ClinicalTrials.gov registry entry for NCT02770170 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 306-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (60% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.