A Biomarker-Driven Approach to Identify Pathogenic Mechanisms and Novel Therapeutic Targets in Chronic Wounds (Pyoderma Gangrenosum) using Tildrakizumab
Liverpool Hospital
10 participants
Mar 2, 2023
Interventional
Conditions
Summary
This study aims to look at measures of disease activity in ulcers (Pyoderma Gangrenosum) and the potential of response to a new therapy, Tildrakizumab, an injection which is administered under the skin every 4 weeks, for a total of 12 weeks. We intend to perform an exploratory analysis for potential biomarkers of disease activity in Pyoderma Gangrenosum (PG). Our proposal would include an open-label study with 12 weeks of treatment with Tildrakizumab in line with the published dosing frequency for Hidradenitis Suppurativa (200mg Week 0,4 and 8). Outcome measures are obtained from a recent systematic review of outcome measures used in clinical trials of PG.
Eligibility
Inclusion Criteria2
- Age greater than or equal to 18 years
- A minimum of one (1) active ulcer of Pyoderma Gangrenosum as determined by the PI
Exclusion Criteria5
- 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
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Interventions
Tildrakizumab 200mg subcutaneous injection every 4 weeks, given via supervised injection in clinic for a total of 12 weeks.
Locations(1)
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ACTRN12623000211662