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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03972280




Registration number
NCT03972280
Ethics application status
Date submitted
31/05/2019
Date registered
3/06/2019

Titles & IDs
Public title
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
Scientific 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
Secondary ID [1] 0 0
2018-002871-17
Secondary ID [2] 0 0
CSL324_1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Palmoplantar Pustulosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Experimental: Dose Level 1 (HS) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS

Experimental: Dose Level 1 (PPP) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP

Experimental: Dose Level 1 (Total) - Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP

Experimental: Dose Level 2 (HS) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS

Experimental: Dose Level 2 (PPP) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP

Experimental: Dose Level 2 (Total) - Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP


Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 24 weeks
Primary outcome [2] 0 0
TEAEs by severity
Timepoint [2] 0 0
Up to 24 weeks
Primary outcome [3] 0 0
TEAEs by casuality
Timepoint [3] 0 0
Up to 24 weeks
Primary outcome [4] 0 0
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Timepoint [4] 0 0
Up to 24 weeks
Primary outcome [5] 0 0
AESIs: Grade 3 and 4 neutropenia by causality
Timepoint [5] 0 0
Up to 24 weeks
Primary outcome [6] 0 0
Incidence of AESIs: Grade 3 and 4 infection
Timepoint [6] 0 0
Up to 24 weeks
Primary outcome [7] 0 0
AESIs: Grade 3 and 4 infection by causality
Timepoint [7] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Timepoint [1] 0 0
Up to 22 days after dose
Secondary outcome [2] 0 0
Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
Timepoint [2] 0 0
Up to 22 days after dose
Secondary outcome [3] 0 0
Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered
Timepoint [3] 0 0
Up to 22 days after dose
Secondary outcome [4] 0 0
Cmax of CSL324 in serum for the last dose administered
Timepoint [4] 0 0
Up to 22 days after dose
Secondary outcome [5] 0 0
Tmax of CSL324 in serum for the last dose administered
Timepoint [5] 0 0
Up to 84 days after dose
Secondary outcome [6] 0 0
AUCtau of CSL324 in serum for the last dose administered
Timepoint [6] 0 0
Up to 22 days after dose
Secondary outcome [7] 0 0
Half life (t½) of CSL324 in serum for the last dose administered
Timepoint [7] 0 0
Up to 84 days after dose
Secondary outcome [8] 0 0
Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered
Timepoint [8] 0 0
Up to 22 days after dose
Secondary outcome [9] 0 0
Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered
Timepoint [9] 0 0
Up to 22 days after dose
Secondary outcome [10] 0 0
Ctrough of CSL324 for each dose of CSL324 administered
Timepoint [10] 0 0
Up to 22 days after each dose
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to 22 days after each dose
Secondary outcome [12] 0 0
Presence of anti-CSL324 antibodies in serum
Timepoint [12] 0 0
Up to 168 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/10/2022
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6160 - Fremantle
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Denmark
State/province [2] 0 0
Hellerup
Country [3] 0 0
Denmark
State/province [3] 0 0
Roskilde
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Bochum
Country [6] 0 0
Germany
State/province [6] 0 0
Darmstadt
Country [7] 0 0
Germany
State/province [7] 0 0
Dresden

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03972280