Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis

May 25, 2023 updated by: CSL Behring

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Holdsworth House Medical Practice
      • Fremantle, Australia, 6160
        • Fremantle Dermatology
      • Parkville, Australia, 3052
        • The Royal Melbourne Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Roskilde, Denmark, 4000
        • Zealand University Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Bochum, Germany, 44791
        • St. Josef Hospital
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Level 1 (HS)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Biological: 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
Other Names:
  • CSL324
Experimental: Dose Level 1 (PPP)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Biological: 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
Other Names:
  • CSL324
Experimental: Dose Level 1 (Total)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Biological: 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
Other Names:
  • CSL324
Experimental: Dose Level 2 (HS)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
Biological: 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
Other Names:
  • CSL324
Experimental: Dose Level 2 (PPP)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
Biological: 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
Other Names:
  • CSL324
Experimental: Dose Level 2 (Total)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
Biological: 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
Other Names:
  • CSL324

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 24 weeks
Up to 24 weeks
TEAEs by severity
Time Frame: Up to 24 weeks
Up to 24 weeks
TEAEs by casuality
Time Frame: Up to 24 weeks
Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Time Frame: Up to 24 weeks
Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
Time Frame: Up to 24 weeks
Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
Time Frame: Up to 24 weeks
Up to 24 weeks
AESIs: Grade 3 and 4 infection by causality
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Time Frame: Up to 22 days after dose
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
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
Up to 22 days after dose
Cmax of CSL324 in serum for the last dose administered
Time Frame: Up to 22 days after dose
Up to 22 days after dose
Tmax of CSL324 in serum for the last dose administered
Time Frame: Up to 84 days after dose
Up to 84 days after dose
AUCtau of CSL324 in serum for the last dose administered
Time Frame: Up to 22 days after dose
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
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
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
Up to 22 days after dose
Ctrough of CSL324 for each dose of CSL324 administered
Time Frame: Up to 22 days after each dose
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
Up to 22 days after each dose
Presence of anti-CSL324 antibodies in serum
Time Frame: Up to 168 days
Up to 168 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSL324_1002
  • 2018-002871-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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