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

Hidradenitis Suppurativa Clinical Trial

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

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
• 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
• 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."

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Palmoplantar Pustulosis
• Psoriasis

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