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CompletedNCT03972280Updated May 26, 2023

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

A Phase 1 interventional study of Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody in Hidradenitis Suppurativa and Palmoplantar Pustulosis, sponsored by CSL Behring. Completed at 11 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-26.

Sponsored by CSL Behring · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hidradenitis Suppurativa
  • Palmoplantar Pustulosis
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 39 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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."
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • BiologicalRecombinant 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

    Also known as: CSL324

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 24 weeks

  2. TEAEs by severity

    Time frame: Up to 24 weeks

  3. TEAEs by casuality

    Time frame: Up to 24 weeks

  4. Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia

    Time frame: Up to 24 weeks

  5. AESIs: Grade 3 and 4 neutropenia by causality

    Time frame: Up to 24 weeks

  6. Incidence of AESIs: Grade 3 and 4 infection

    Time frame: Up to 24 weeks

  7. AESIs: Grade 3 and 4 infection by causality

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Maximum concentration (Cmax) of CSL324 in serum for the first dose administered

    Time frame: Up to 22 days after dose

  2. Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered

    Time frame: Up to 22 days after dose

  3. 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

  4. Cmax of CSL324 in serum for the last dose administered

    Time frame: Up to 22 days after dose

  5. Tmax of CSL324 in serum for the last dose administered

    Time frame: Up to 84 days after dose

  6. AUCtau of CSL324 in serum for the last dose administered

    Time frame: Up to 22 days after dose

  7. Half life (t½) of CSL324 in serum for the last dose administered

    Time frame: Up to 84 days after dose

  8. Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered

    Time frame: Up to 22 days after dose

  9. 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

  10. Ctrough of CSL324 for each dose of CSL324 administered

    Time frame: Up to 22 days after each dose

  11. 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

  12. Presence of anti-CSL324 antibodies in serum

    Time frame: Up to 168 days

07

Study locations

11 sites
  • 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
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03972280
Lead sponsor
CSL Behring
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
Jul 4, 2019
Primary completion
Oct 4, 2022
Completion
Oct 4, 2022
Last update
May 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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