Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with vitiligo.
Tildrakizumab is a monoclonal antibody against interleukin (IL) 23, specifically anti-IL23p19. It is approved in the USA, Europe and Australia for psoriasis. The psoriasis dose is 100mg administered subcutaneously at weeks 0, 4 and every 12 weeks. Recent research has shown medications used to treat psoriasis may be effective in other immune mediated or autoimmune diseases such as vitiligo. With studies underway assessing the effect of Janus Kinase (JAK) inhibitors in psoriasis and vitiligo, this study seeks to determine if an IL-23 inhibitor is beneficial in halting disease progression and inducing repigmentation in vitiligo. There is some data to indicate that a higher dose of Tildrakizumab is effective for other autoimmune diseases such as psoriasis and hidradenitis suppurativa. For psoriasis, 200mg dosage was more effective than 100mg dosage. For hidradenitis suppurativa, a dosage of 200mg every 4 weeks was shown to be effective. Patients included in this study will start Tildrakizumab at a dosage of 200mg every 4 weeks for 6 months. There is a total of 8 visits involved in this study. Tildrakizumab is provided during visit 2, 3, 4, 5, 6, 7. Visit 1is a screening visit. At visit 1 and visit 8 no study drug will be provided.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
2 100mg subcutaneous injections Q4W
Premier Specialists Pty Ltd
Sydney, New South Wales, Australia
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Time frame: Week 24
Percentage repigmentation: Vitiligo Extent Score (VES)
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Time frame: Week 24
Percentage repigmentation: Photographs
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Time frame: Week 24
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Time frame: Week 12
Percentage repigmentation: Vitiligo Extent Score (VES)
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Time frame: Week 12
Percentage repigmentation: Photographs
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Time frame: Week 12
Time to repigmentation
Time frame: through study treatment completion at 24-weeks
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Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)
Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse
Time frame: Baseline through week 12 and through study treatment completion at 24-weeks
Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC)
1-tem questionnaire designed to assess a subject's impression of disease improvement. 7 point Likert scale ranging from "Very much better" to "Very much worse" with "no change" in the middle. Range\[1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better/a definite improvement, 7-a great deal better\]. Higher score=better impression of change/better
Time frame: Baseline through week 12 and through study treatment completion at 24-weeks
Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES)
Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse.
Time frame: Baseline through week 12 and through study treatment completion at 24-weeks
Adverse events
incidence and nature of any adverse events
Time frame: through study treatment completion at 24-weeks