Trials / Completed
CompletedNCT02770170
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | BI 655064 dose 1 | |
| DRUG | BI 655064 dose 2 | |
| DRUG | BI 655064 dose 3 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-05-16
- Primary completion
- 2020-06-23
- Completion
- 2020-08-18
- First posted
- 2016-05-12
- Last updated
- 2025-10-16
- Results posted
- 2021-07-12
Locations
74 sites across 20 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
Source: ClinicalTrials.gov record NCT02770170. Inclusion in this directory is not an endorsement.