Phase 2
N=121
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Lupus Nephritis
Bottom Line
View on ClinicalTrials.gov: NCT02770170 ↗Enrolled (actual)
121
Serious AEs
24.8%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Patients With Complete Renal Response (CRR) at Week 52 — 38.32; 44.95; 44.56; 48.33 Percentage of Participants — p=0.7271
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BI 655064 dose 1 (Drug); BI 655064 dose 2 (Drug); BI 655064 dose 3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Complete Renal Response (CRR) at Week 52 |
38.32; 44.95; 44.56; 48.33 | 0.7271 |
| SECONDARY Percentage of Patients With Complete Renal Response (CRR) at Week 26 |
28.6; 50.0; 35.0; 37.5 | 0.5773 |
| SECONDARY Percentage of Patients With Partial Renal Response (PRR) at Week 26 |
42.9; 75.0; 62.5; 62.5 | 0.1476 |
| SECONDARY Percentage of Patients With Partial Renal Response (PRR) at Week 52 |
33.3; 65.0; 55.0; 60.0 | 0.0512 |
| SECONDARY Percentage of Patients With Major Renal Response (MRR) at Week 26 |
28.6; 55.0; 37.5; 50.0 | 0.1269 |
| SECONDARY Percentage of Patients With Major Renal Response (MRR) at Week 52 |
42.9; 55.0; 52.5; 52.5 | 0.5687 |
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.
Eligibility Criteria
Inclusion criteria
- Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
- Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
- Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]
- Signed and dated written informed consent
Exclusion criteria
- Clinically significant current other renal disease
- Glomerular Filtration Rate 2 x Upper Limit of Normal
- Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02770170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.