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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitiligo Patients on Tildrakizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tildrakizumab | Drug | 2 100mg subcutaneous injections Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 24 |
| Percentage repigmentation: Photographs | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
| Percentage repigmentation: Vitiligo Extent Score (VES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dedee Murrell, MD | University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Specialists Pty Ltd | Sydney | New South Wales | 2217 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32441048 | Background | Jerjen R, Moodley A, Sinclair R. Repigmentation of acrofacial vitiligo with subcutaneous tildrakizumab. Australas J Dermatol. 2020 Nov;61(4):e446-e448. doi: 10.1111/ajd.13346. Epub 2020 May 21. No abstract available. | |
| 25427848 | Background | Vaccaro M, Cannavo SP, Imbesi S, Cristani M, Barbuzza O, Tigano V, Gangemi S. Increased serum levels of interleukin-23 circulating in patients with non-segmental generalized vitiligo. Int J Dermatol. 2015 Jun;54(6):672-4. doi: 10.1111/ijd.12392. Epub 2014 Nov 27. |
| Label | URL |
|---|---|
| Premier Specialists Dermatology | View source |
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| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010859 | Pigmentation Disorders |
| D017496 | Hypopigmentation |
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000598434 | tildrakizumab |
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Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse |
| Week 12 |
| Percentage repigmentation: Photographs | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. | Week 12 |
| Time to repigmentation | through study treatment completion at 24-weeks |
| 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 | 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 | 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. | Baseline through week 12 and through study treatment completion at 24-weeks |
| Adverse events | incidence and nature of any adverse events | through study treatment completion at 24-weeks |
| 31172649 | Background | Hu Y, Qi X, Hu Y, Lu Y, Liu K, Han X, Mao Z, Wu Z, Zhou X. Effects of CO2 fractional laser therapy on peripheral blood cytokines in patients with vitiligo. Dermatol Ther. 2019 Jul;32(4):e12992. doi: 10.1111/dth.12992. Epub 2019 Jun 17. |
| 15210457 | Background | Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677. |
| 26827762 | Background | van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Speeckaert R. Development and Validation of the Vitiligo Extent Score (VES): an International Collaborative Initiative. J Invest Dermatol. 2016 May;136(5):978-984. doi: 10.1016/j.jid.2015.12.040. Epub 2016 Jan 28. |
| 8033378 | Background | Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. |
| 27887798 | Background | van Geel N, Lommerts JE, Bekkenk MW, Prinsen CA, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Wolkerstorfer A, Speeckaert R; international Vitiligo Score Working Group. Development and validation of a patient-reported outcome measure in vitiligo: The Self Assessment Vitiligo Extent Score (SA-VES). J Am Acad Dermatol. 2017 Mar;76(3):464-471. doi: 10.1016/j.jaad.2016.09.034. Epub 2016 Nov 22. |