Expanded Access Policy
Vitaeris’ objective is to provide access to clazakizumab at the appropriate time and in the correct manner for patients.
At this time, participation in a controlled clinical trial is the most appropriate way to access the use of clazakizumab. Clinical trials are controlled research studies in humans designed to determine if an investigational drug is safe and effective. Since the benefit:risk profile of clazakizumab has not been fully established, Vitaeris is not supporting expanded access to clazakizumab outside of clinical trials. Vitaeris is maintaining a focus on conducting well-controlled clinical trials that can support global health authority approvals.
Vitaeris is currently conducting a pivotal trial investigating the efficacy and safety of clazakizumab for the treatment of chronic active antibody-mediated rejection (CABMR) in kidney transplant subjects.
If you have questions about expanded access, please speak with your physician or have your physician contact firstname.lastname@example.org. We anticipate responding to inquiries sent to this email within five business days.