At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
BI 655064 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
In Brief
A Phase 2 clinical trial evaluating BI 655064 and Placebo for Lupus Nephritis. Completed, enrolled 69 participants across 36 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesAustralia, Canada, Czechia, Germany, Greece, Hong Kong, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, South Korea, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartJan 2018
Primary CompletionMay 2021
Study CompletionJul 2021
TodayJul 2026
First PostedDec 28, 2017
Enrollment StartJan 9, 2018
Primary CompletionMay 25, 2021
Study CompletionJul 27, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.5 years ago
Interventions
BI 655064drug
subcutaneous injection
Placebodrug
subcutaneous injection