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An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

NCT03385564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2022-07-13

Study results available
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Summary

The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.

Conditions

Interventions

DRUG

BI 655064

subcutaneous injection

DRUG

Placebo

subcutaneous injection

Sponsors & Collaborators

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
2018-01-09
Primary Completion
2021-05-25
Completion
2021-07-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Germany
  • Greece
  • Hong Kong
  • Japan
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • South Korea
  • 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 NCT03385564 on ClinicalTrials.gov