BI 655064 in patients with active lupus nephritis.
Research type
Research Study
Full title
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.
IRAS ID
199109
Contact name
Karine Pemberton
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2015-001750-15
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This is a double-blind, randomised, placebo-controlled trial to investigate the efficacy and safety of BI 655064 in
patients with active lupus nephritis. All eligible patients will be assigned by random choice to receive either the investigational BI 655064 or the placebo, on top of the standard of care treatment for Lupus Nephritis. Patients will have a chance of being placed in any of the following groups:
Group A : 1/3 of patients will receive placebo – 40 patients; Group B: 1/6 of patients will receive a low dose of the investigational drug BI 655064 – 20 patients; Group C: 1/6 of patients will receive a medium dose of the investigational drug BI 655064 – 20 patients; Group D: 1/3 of patients will receive a high dose of the investigational drug BI 655064 – 40 patients study will be performed by investigators specialised in the
treatment of lupus nephritis. The investigational drug BI 655064 is to be injected under the skin (subcutaneous) once a week. It is estimated that approximately four people will participate in this trial in the United Kingdom and approximately 120 participants worldwide. Each patient’s participation in the trial will last approximately 15 months and will require approximately 18 visits to the trial clinic.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0183
Date of REC Opinion
1 Jul 2016
REC opinion
Further Information Favourable Opinion