A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
- Autoimmune Disorder
- Giant Cell Arteritis
Completed
- Basel
- Bern
NCT03923738 2018-004718-17 WP41152
Trial Summary
This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
Eligibility Criteria
- Diagnosis of GCA as classified according to protocol-specified criteria;
- Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.
- Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
- Evidence of serious uncontrolled disease;
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
- Active TB requiring treatment within the previous 3 years.
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