Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
NCT ID: NCT03972280
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2019-07-04
2022-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Level 1 (HS)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
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
Dose Level 1 (PPP)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
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
Dose Level 1 (Total)
Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
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
Dose Level 2 (HS)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS
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
Dose Level 2 (PPP)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP
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
Dose Level 2 (Total)
Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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."
18 Years
75 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Locations
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Holdsworth House Medical Practice
Darlinghurst, , Australia
Fremantle Dermatology
Fremantle, , Australia
The Royal Melbourne Hospital
Parkville, , Australia
Westmead Hospital
Westmead, , Australia
Bispebjerg Hospital
Copenhagen, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Charité - Universitätsmedizin Berlin
Berlin, , Germany
St. Josef Hospital
Bochum, , Germany
Klinikum Darmstadt
Darmstadt, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Countries
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Other Identifiers
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2018-002871-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL324_1002
Identifier Type: -
Identifier Source: org_study_id
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