A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

Roche

Status and phase: Completed; Phase 1

Conditions: Giant Cell Arteritis

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03923738

WP41152

2018-004718-17 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

TCZ IV Q4W

Experimental group

Description:

Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.

Treatment:

Drug: Tocilizumab