NCT03385564

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Initially planned participating countries: Argentina, Australia, Canada, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Malaysia, Mexico, Philippines, Poland, Portugal, Serbia, Spain, Taiwan, Thailand, United Kingdom, United States

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	BI 655064	subcutaneous injection
DRUG	Placebo	subcutaneous injection

Timeline

• Start date: 2018-01-09
• Primary completion: 2021-05-25
• Completion: 2021-07-27
• First posted: 2017-12-28
• Last updated: 2022-07-13
• Results posted: 2022-07-13

Locations

36 sites across 16 countries: United States, Australia, Canada, Czechia, Germany, Greece, Hong Kong, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, South Korea, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study