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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03972280
Other study ID # CSL324_1002
Secondary ID 2018-002871-17
Status Completed
Phase Phase 1
First received
Last updated
Start date July 4, 2019
Est. completion date October 4, 2022

Study information

Verified date May 2023
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 4, 2022
Est. primary completion date October 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Australia Holdsworth House Medical Practice Darlinghurst
Australia Fremantle Dermatology Fremantle
Australia The Royal Melbourne Hospital Parkville
Australia Westmead Hospital Westmead
Denmark Bispebjerg Hospital Copenhagen
Denmark Gentofte Hospital Hellerup
Denmark Zealand University Hospital Roskilde
Germany Charité - Universitätsmedizin Berlin Berlin
Germany St. Josef Hospital Bochum
Germany Klinikum Darmstadt Darmstadt
Germany Universitätsklinikum Carl Gustav Carus Dresden

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Australia,  Denmark,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) Up to 24 weeks
Primary TEAEs by severity Up to 24 weeks
Primary TEAEs by casuality Up to 24 weeks
Primary Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia Up to 24 weeks
Primary AESIs: Grade 3 and 4 neutropenia by causality Up to 24 weeks
Primary Incidence of AESIs: Grade 3 and 4 infection Up to 24 weeks
Primary AESIs: Grade 3 and 4 infection by causality Up to 24 weeks
Secondary Maximum concentration (Cmax) of CSL324 in serum for the first dose administered Up to 22 days after dose
Secondary Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered Up to 22 days after dose
Secondary Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered Up to 22 days after dose
Secondary Cmax of CSL324 in serum for the last dose administered Up to 22 days after dose
Secondary Tmax of CSL324 in serum for the last dose administered Up to 84 days after dose
Secondary AUCtau of CSL324 in serum for the last dose administered Up to 22 days after dose
Secondary Half life (t½) of CSL324 in serum for the last dose administered Up to 84 days after dose
Secondary Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered Up to 22 days after dose
Secondary Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered Up to 22 days after dose
Secondary Ctrough of CSL324 for each dose of CSL324 administered Up to 22 days after each dose
Secondary 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) Up to 22 days after each dose
Secondary Presence of anti-CSL324 antibodies in serum Up to 168 days
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