Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000211662
Ethics application status
Approved
Date submitted
16/02/2023
Date registered
28/02/2023
Date last updated
13/09/2023
Date data sharing statement initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Biomarker-Driven Approach to Identify Pathogenic Mechanisms and Novel Therapeutic Targets in Chronic Wounds (Pyoderma Gangrenosum) using Tildrakizumab
Scientific title
A Biomarker-Driven Approach to Identify Pathogenic Mechanisms and Novel Therapeutic Targets in Chronic Wounds (Pyoderma Gangrenosum) using Tildrakizumab
Secondary ID [1] 309014 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pyoderma Gangrenosum 329060 0
Condition category
Condition code
Inflammatory and Immune System 326042 326042 0 0
Other inflammatory or immune system disorders
Skin 326077 326077 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tildrakizumab 200mg subcutaneous injection every 4 weeks, given via supervised injection in clinic for a total of 12 weeks.
Intervention code [1] 325457 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333899 0
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline (composite primary outcome) using skin biopsy
Timepoint [1] 333899 0
Week 12 post-first dose
Secondary outcome [1] 418661 0
Safety and Tolerability (Grade 2/3 Adverse Effects); examples of known events include injection site reactions, upper respiratory tract infections. These will be assessed by history taking and clinical examination.
Timepoint [1] 418661 0
Week 12 post first dose
Secondary outcome [2] 418805 0
Changes in Disease Activity (Measures by size of ulcer and global assessment VAS) using analysis of digital photographs
Timepoint [2] 418805 0
Week 12 post first dose

Eligibility
Key inclusion criteria
• Age greater than or equal to 18 years
• A minimum of one (1) active ulcer of Pyoderma Gangrenosum as determined by the PI
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
• Individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer).
• Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
• Have received a vaccination with a live viral of bacterial component within 4 weeks or less of intended Tildrakizumab administration
• Patients not willing to abstain from receiving live vaccinations during treatment and for at least 17 weeks after treatment

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2023
Actual
2/03/2023
Date of last participant enrolment
Anticipated
1/05/2023
Actual
1/05/2023
Date of last data collection
Anticipated
Actual
10/08/2023
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313227 0
Commercial sector/Industry
Name [1] 313227 0
Sun Pharma
Country [1] 313227 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth St Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 314983 0
None
Name [1] 314983 0
Address [1] 314983 0
Country [1] 314983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312457 0
South Western Sydney Local Health District
Ethics committee address [1] 312457 0
Ethics committee country [1] 312457 0
Australia
Date submitted for ethics approval [1] 312457 0
Approval date [1] 312457 0
26/10/2021
Ethics approval number [1] 312457 0

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

Contacts
Principal investigator
Name 124734 0
Dr John Frew
Address 124734 0
Department of Dermatology, Liverpool Hospital ,
Suite 7, Level 1, 45-47 Goulburn St
Liverpool NSW 2170
Country 124734 0
Australia
Phone 124734 0
+61 2 87384560
Fax 124734 0
Email 124734 0
john.frew@unsw.edu.au
Contact person for public queries
Name 124735 0
John Frew
Address 124735 0
Department of Dermatology,
Liverpool Hospital
Suite 7, Level 1, 45-47 Goulburn St
Liverpool NSW 2170
Country 124735 0
Australia
Phone 124735 0
+61 2 87384560
Fax 124735 0
Email 124735 0
john.frew@unsw.edu.au
Contact person for scientific queries
Name 124736 0
John Frew
Address 124736 0
Department of Dermatology,
Liverpool Hospital Suite 7, Level 1, 45-47 Goulburn St
Liverpool NSW 2170
Country 124736 0
Australia
Phone 124736 0
+61 2 87384560
Fax 124736 0
Email 124736 0
john.frew@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.