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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223278

Enrollment

120

Registered

2016-08-01

Start date

2016-08-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Interventions

investigational material(s) Generic name etc : BI 655064 INN of investigational material : - Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females, age 18 - 70 (inclusive) years 2. Diagnosis of systemic lupus erythematosus (SLE) 3. Lupus Nephritis Class III or IV proven by renal biopsy 4. Active renal disease evidenced by proteinuria etc.

Exclusion criteria

Exclusion criteria: 1.Clinically significant current other renal diseases 2.GFR < 30 ml/min/1.73m2 3.Dialysis within 12 months of screening 4.Antiphospholipid syndrome 5.Diabetes mellitus if poorly controlled according to investigator or known diabetic retinopathy or diabetic nephropathy etc.

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of patients with Complete Renal Response at week 52	—

Secondary

Measure	Time frame
efficacy Proportion of patients with Complete renal response at week 26 efficacy Proportion of patients with Partial renal response at week 26 and 52	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026