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

NCT02770170 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-10-16

Study results available
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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

Interventions

DRUG

BI 655064 dose 1

DRUG

BI 655064 dose 2

DRUG

BI 655064 dose 3

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2020-06-23
Completion
2020-08-18

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Serbia
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770170 on ClinicalTrials.gov