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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03972280
Registration number
NCT03972280
Ethics application status
Date submitted
31/05/2019
Date registered
3/06/2019
Date last updated
26/05/2023
Titles & IDs
Public title
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
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Scientific title
A Multicenter, Open-label, 2-regimen, Repeat-dose Study to Assess the Safety and Pharmacokinetics of Intravenous CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
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Secondary ID [1]
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2018-002871-17
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Secondary ID [2]
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CSL324_1002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Palmoplantar Pustulosis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
Experimental: Dose Level 1 (HS) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Experimental: Dose Level 1 (PPP) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Experimental: Dose Level 1 (Total) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Experimental: Dose Level 2 (HS) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Experimental: Dose Level 2 (PPP) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Experimental: Dose Level 2 (Total) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Other interventions: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 24 weeks
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Primary outcome [2]
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TEAEs by severity
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks
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Primary outcome [3]
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TEAEs by casuality
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Assessment method [3]
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Timepoint [3]
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Up to 24 weeks
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Primary outcome [4]
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Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
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Assessment method [4]
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Timepoint [4]
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Up to 24 weeks
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Primary outcome [5]
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AESIs: Grade 3 and 4 neutropenia by causality
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Assessment method [5]
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Timepoint [5]
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Up to 24 weeks
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Primary outcome [6]
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Incidence of AESIs: Grade 3 and 4 infection
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Assessment method [6]
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Timepoint [6]
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Up to 24 weeks
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Primary outcome [7]
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AESIs: Grade 3 and 4 infection by causality
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Assessment method [7]
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Timepoint [7]
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Up to 24 weeks
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Secondary outcome [1]
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Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
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Assessment method [1]
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Timepoint [1]
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Up to 22 days after dose
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Secondary outcome [2]
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Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
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Assessment method [2]
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Timepoint [2]
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Up to 22 days after dose
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Secondary outcome [3]
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Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered
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Assessment method [3]
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Timepoint [3]
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Up to 22 days after dose
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Secondary outcome [4]
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Cmax of CSL324 in serum for the last dose administered
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Assessment method [4]
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Timepoint [4]
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Up to 22 days after dose
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Secondary outcome [5]
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Tmax of CSL324 in serum for the last dose administered
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Assessment method [5]
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Timepoint [5]
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Up to 84 days after dose
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Secondary outcome [6]
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AUCtau of CSL324 in serum for the last dose administered
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Assessment method [6]
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Timepoint [6]
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Up to 22 days after dose
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Secondary outcome [7]
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Half life (t½) of CSL324 in serum for the last dose administered
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Assessment method [7]
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Timepoint [7]
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Up to 84 days after dose
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Secondary outcome [8]
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Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered
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Assessment method [8]
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Timepoint [8]
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Up to 22 days after dose
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Secondary outcome [9]
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Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered
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Assessment method [9]
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Timepoint [9]
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Up to 22 days after dose
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Secondary outcome [10]
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Ctrough of CSL324 for each dose of CSL324 administered
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Assessment method [10]
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Timepoint [10]
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Up to 22 days after each dose
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Secondary outcome [11]
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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)
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Assessment method [11]
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Timepoint [11]
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Up to 22 days after each dose
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Secondary outcome [12]
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Presence of anti-CSL324 antibodies in serum
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Assessment method [12]
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Timepoint [12]
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Up to 168 days
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Eligibility
Key inclusion criteria
- Male or female subjects between 18 and 75 years of age, inclusive
- Confirmed clinical diagnosis of moderate to severe HS as per International
Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 = 4)
- PPP differentiated from other forms of pustulosis
- Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI)
score of = 12.
- Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of
oral antibiotics for treatment of HS
- Subjects with PPP only: confirmed clinical diagnosis of PPP at least 6 months before
Screening and inadequate response to topical therapy, phototherapy, and / or previous
systemic therapy for the treatment of PPP
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treatment with any medications and therapies not permitted during the study.
- History of myeloproliferative disease.
- Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer,
carcinoma in situ, or prostate cancer not requiring treatment.
- Current, or a recent clinically significant history of, uncontrolled renal,
hepatic(including currently active hepatitis B virus and / or hepatitis C virus),
hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as
potentially having an effect on study outcomes as determined by the Investigator and /
or Sponsor.
- Congenital or acquired immunosuppressive condition(s), including human
immunodeficiency virus infection.
- Clinical signs of active infection and / or fever > 38°C during the 7 days before Day
1.
- Clinically significant abnormalities on physical examination, ECG, or laboratory
assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L) at
Screening.
- Subjects with PPP only: concurrent psoriasis vulgaris (not including scaly scalp and /
or ears).
- Subjects with HS only: > 20 draining fistulas."
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/10/2022
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Sample size
Target
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Darlinghurst
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Recruitment hospital [2]
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Fremantle Dermatology - Fremantle
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Recruitment hospital [3]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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6160 - Fremantle
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Copenhagen
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Country [2]
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Denmark
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State/province [2]
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Hellerup
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Country [3]
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Denmark
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State/province [3]
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Roskilde
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Country [4]
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Germany
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State/province [4]
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Berlin
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Country [5]
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Germany
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State/province [5]
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Bochum
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Country [6]
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Germany
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State/province [6]
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Darmstadt
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Country [7]
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Germany
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State/province [7]
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Dresden
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03972280
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03972280
Download to PDF