Study CSL324\_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
Holdsworth House Medical Practice
Darlinghurst, Australia
Fremantle Dermatology
Fremantle, Australia
The Royal Melbourne Hospital
Parkville, Australia
Westmead Hospital
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 24 weeks
TEAEs by severity
Time frame: Up to 24 weeks
TEAEs by casuality
Time frame: Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Time frame: Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
Time frame: Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
Time frame: Up to 24 weeks
AESIs: Grade 3 and 4 infection by causality
Time frame: Up to 24 weeks
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Cmax of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
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Westmead, Australia
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Zealand University Hospital
Roskilde, Denmark
Charité - Universitätsmedizin Berlin
Berlin, Germany
St. Josef Hospital
Bochum, Germany
Klinikum Darmstadt
Darmstadt, Germany
...and 1 more locations
Tmax of CSL324 in serum for the last dose administered
Time frame: Up to 84 days after dose
AUCtau of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Half life (t½) of CSL324 in serum for the last dose administered
Time frame: Up to 84 days after dose
Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Ctrough of CSL324 for each dose of CSL324 administered
Time frame: Up to 22 days after each dose
Accumulation ratio for AUCtau (ratio between AUCtau of the last dose and of the first dose) and accumulation ratio for Cmax (ratio between Cmax of the last dose and of the first dose)
Time frame: Up to 22 days after each dose
Presence of anti-CSL324 antibodies in serum
Time frame: Up to 168 days