Boehringer Ingelheim has commenced a clinical study of its new adalimumab biosimilar candidate BI 695501.
VOLTAIRE-X is an interchangeability study that aims to demonstrate that BI 695501 is interchangeable with AbbVie’s Humira, the branded drug upon which this biosimilar is based.
240 patients with moderate to severe chronic plaque psoriasis will be enrolled on the study, which will assess safety, immunogenicity and efficacy.
Pharmacokinetics and clinical outcomes will also be compared between patients receiving Humira continuously and those who switch repeatedly between Humira and BI 695501.
The findings of the trial set to support regulatory applications for the therapy. Results from the study are expected in the second half of 2019.