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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2016-05-16 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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