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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972280
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Palmoplantar Pustulosis Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : October 4, 2022
Actual Study Completion Date : October 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CSL324


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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."
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972280


Locations
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Australia
Holdsworth House Medical Practice
Darlinghurst, Australia, 2010
Fremantle Dermatology
Fremantle, Australia, 6160
The Royal Melbourne Hospital
Parkville, Australia, 3052
Westmead Hospital
Westmead, Australia, 2145
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Gentofte Hospital
Hellerup, Denmark, 2900
Zealand University Hospital
Roskilde, Denmark, 4000
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
St. Josef Hospital
Bochum, Germany, 44791
Klinikum Darmstadt
Darmstadt, Germany, 64283
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Sponsors and Collaborators
CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03972280    
Other Study ID Numbers: CSL324_1002
2018-002871-17 ( EudraCT Number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Psoriasis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Skin Diseases, Infectious
Suppuration
Skin Diseases, Papulosquamous
Antibodies
Antibodies, Monoclonal
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic