CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 121 enrolled
Drug / intervention
BI 655064 dose 1 +3 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18-70 years
  • ✓SLE diagnosis by ACR 1997 criteria (≥4 criteria) with anti-dsDNA or ANA positivity
  • ✓Lupus Nephritis Class III or IV with active or active/chronic disease confirmed by renal biopsy within 3 months
  • ✓Active renal disease with proteinuria ≥1.0 g/day
Key exclusion· 8
  • ✕GFR <30 ml/min/1.73m²
  • ✕Dialysis within 12 months of screening
  • ✕Antiphospholipid syndrome
  • ✕Poorly controlled diabetes or diabetic retinopathy/nephropathy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02770170
NCT02770170Phase 2Completed
CompareCT.gov

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis

Boehringer Ingelheim·interventional·Posted May 12, 2016·Updated Oct 16, 2025

In Brief

A Phase 2 clinical trial evaluating BI 655064 dose 1, BI 655064 dose 2, and 2 other interventions for Lupus Nephritis. Completed, enrolled 121 participants across 74 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesAustralia, Canada, Czechia, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, Serbia, South Korea, Spain, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartMay 16, 2016
Primary CompletionJun 23, 2020
Study CompletionAug 18, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.1 years ago

Interventions

BI 655064 dose 1drug

BI 655064 dose 2drug

BI 655064 dose 3drug

Placebodrug