VOCAL-EXT
Research type
Research Study
Full title
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects with Lupus Nephritis
IRAS ID
1006038
Contact name
Aleks Perenic
Contact email
Sponsor organisation
Aurinia Pharmaceuticals Inc.
Research summary
Participants who are enrolled in the Aurinia Pharmaceuticals VOCAL study will be invited to participate in this extension study (VOCAL-EXT).
This is a clinical research study of an investigational drug called voclosporin in children and adolescents with lupus nephritis (LN)(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 oral treatments in the US or EU for the treatment of LN in children or adolescents, however the US recently approved belimumab as a iv treatment for patients 5 years and older with active LN.
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.
In VOCAL-EXT study participants will be provided with voclosporin for up to an additional year. The aim of the VOCAL-EXT study is to provide voclosporin treatment added to standard treatment. The study is designed to investigate the safety and efficacy (how well the drug works) in children or adolescents over an additional period of 12 months, giving a total study period of 18 months from the start of VOCAL.
Upon entry into the extension study, participants will start with voclosporin at the same number of capsules as they were taking on completion of the VOCAL study. They will continue to take the same additional standard treatment during the extension study as instructed by their study doctor. The VOCAL-EXT study will include up to 8 scheduled visits. Procedures at the clinic visits include having blood and urine samples taken and ECG assessments. Up to approximately forty children and adolescents (aged 12 – 17 years) will participate in this study at multiple hospital sites around the world.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0378
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion