Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
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
2 other identifiers
interventional
39
3 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2019
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
July 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2022
CompletedMay 26, 2023
May 1, 2023
3.3 years
May 31, 2019
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
Incidence of treatment-emergent adverse events (TEAEs)
Up to 24 weeks
TEAEs by severity
Up to 24 weeks
TEAEs by casuality
Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
Up to 24 weeks
AESIs: Grade 3 and 4 infection by causality
Up to 24 weeks
Secondary Outcomes (12)
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Up to 22 days after dose
Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
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
Up to 22 days after dose
Cmax of CSL324 in serum for the last dose administered
Up to 22 days after dose
Tmax of CSL324 in serum for the last dose administered
Up to 84 days after dose
- +7 more secondary outcomes
Study Arms (6)
Dose Level 1 (HS)
EXPERIMENTALDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Dose Level 1 (PPP)
EXPERIMENTALDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Dose Level 1 (Total)
EXPERIMENTALDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Dose Level 2 (HS)
EXPERIMENTALDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Dose Level 2 (PPP)
EXPERIMENTALDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Dose Level 2 (Total)
EXPERIMENTALDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Interventions
Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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."
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (11)
Holdsworth House Medical Practice
Darlinghurst, 2010, Australia
Fremantle Dermatology
Fremantle, 6160, Australia
The Royal Melbourne Hospital
Parkville, 3052, Australia
Westmead Hospital
Westmead, 2145, Australia
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
St. Josef Hospital
Bochum, 44791, Germany
Klinikum Darmstadt
Darmstadt, 64283, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 3, 2019
Study Start
July 4, 2019
Primary Completion
October 4, 2022
Study Completion
October 4, 2022
Last Updated
May 26, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
- Access Criteria
- Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.