drugset / Trial / NCT03385564
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2018-01-09
- Primary completion
- 2021-05-25
- Completion
- 2021-07-27
Outcome
Missed primary endpoint
registry analysis (other test); BI 655064 120 mg vs Placebo; p = 0.7957; Difference -5.68 (80% CI -34.192 to 22.825); Regression, Logistic NCT03385564 ↗
registry analysis (other test); BI 655064 180 mg vs Placebo; p = 0.5811; Difference -9.37 (80% CI -31.178 to 12.440); Regression, Logistic NCT03385564 ↗
registry analysis (other test); BI 655064 240 mg vs Placebo; p = 0.8972; Difference 1.97 (80% CI -17.534 to 21.480); Regression, Logistic NCT03385564 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 655064 | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | BI 655064 | Monoclonal antibody | 180 mg | Subcutaneous |
| Subject | BI 655064 | Monoclonal antibody | 240 mg | Subcutaneous |