Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
NCT02770170 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02770170 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02770170?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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