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

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ClinicalTrials.gov Identifier: NCT03972280
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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




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 ]


Information from the National Library of Medicine

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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.

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 nonmalignant skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
  • Current, or a recent clinically significant history of, uncontrolled renal, hepatic, 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.
  • Subjects with HS only: > 20 draining fistulas."

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


Contacts
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Contact: Trial Register Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Australia
Fremantle Dermatology Recruiting
Fremantle, Australia
The Royal Melbourne Hospital Recruiting
Parkville, Australia
Westmead Hospital Recruiting
Westmead, Australia
Sponsors and Collaborators
CSL Behring

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03972280     History of Changes
Other Study ID Numbers: CSL324_1002
2018-002871-17 ( EudraCT Number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
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
Skin Diseases, Infectious
Infection
Suppuration
Skin Diseases, Papulosquamous
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Lenograstim
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic