VOCAL
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis
IRAS ID
1004443
Contact name
Aleks Perenic
Contact email
Sponsor organisation
Aurinia Pharmaceuticals Inc.
Eudract number
2020-005807-37
Clinicaltrials.gov Identifier
Research summary
This is a clinical research study of an investigational drug called voclosporin in children and adolescents with lupus nephritis (inflammation of the kidney caused by lupus).
Voclosporin is approved for use in the United States for the treatment of adult patients with lupus nephritis. There are no approved medicines in the US or Europe approved specifically for treatment of lupus nephritis in children or adolescents.
Voclosporin belongs to a class of medications called “immunosuppressants”, which means it prevents certain functions of the immune system. Studies have shown voclosporin has the potential to work in a similar manner as other immunosuppressants, but at a lower dose and potentially fewer side effects.
The aim of this study is to investigate whether voclosporin, added to standard treatment, is able to reduce activity of the disease and to determine its safety as well as the best dose for treatment of lupus nephritis in children or adolescents.
If eligible, participants will be assigned to one of four treatment groups depending on the timing of when they join the study. Participants the first two groups will be randomized (assigned by chance by a computer) to receive voclosporin or placebo (placebo looks like voclosporin but does not contain active drug). The use of a placebo helps to make sure that any side effects and tests during the study are judged fairly. Participants in the later groups 3 and 4 will receive volclosporin.
Participants who agree to join the study will enter a screening period for up to 30 days. If suitable, after that there are 12 study visits over 6-7 months. Procedures at the clinic visits include having blood and urine samples taken and ECG assessments.
Approximately forty children and adolescents (aged 12 – 17 years) will participate in this study at multiple hospital sites around the world.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0027
Date of REC Opinion
17 Mar 2022
REC opinion
Further Information Favourable Opinion