Phase 1 N=24 Treatment

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

Giant Cell Arteritis

Bottom Line

View on ClinicalTrials.gov: NCT03923738 ↗

Enrolled (actual)

Serious AEs

8.7%

Results posted

Dec 2021

Primary outcome: Primary: Maximum Serum Concentration (Cmax) of TCZ — 197; 178 ug/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tocilizumab (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Serum Concentration (Cmax) of TCZ	197; 178	—
PRIMARY Trough Serum Concentration (Ctrough) of TCZ at Steady State	37.2; 22.7	—
PRIMARY Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State	2130; 1610	—
PRIMARY Percentage of Participants With Adverse Events	79.2; 40.9	—
SECONDARY Serum Concentration of Interleukin-6 (IL-6)	57.80; 39.46; 56.03; 49.73; 97.57; 43.04	—
SECONDARY Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)	665.8; 671.3; 680.8; 670.9; 654.6; 651.7	—
SECONDARY Serum Concentration of C-Reactive Protein (CRP)	0.615; 0.356; 0.511; 0.591; 0.426; 0.403	—
SECONDARY Erythrocyte Sedimentation Rate (ESR)	6.1; 5.6; 4.7; 5.6; 7.2; 5.0	—

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03923738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.