Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Conditions
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Skin and Connective Tissue Diseases, Skin Diseases, Pigmentation Disorder, Hypopigmentation, Biologic, Vitiligo

Intervention / Treatment
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* Drug: Tildrakizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Diagnosis of vitiligo Clinically stable vitiligo: defined as no new vitiligo patches and no enlargement of existing patches in previous 3 months. Able to provide voluntary, written, informed consent Exclusion Criteria: Clinically active vitiligo: defined as new vitiligo patches or enlargement of existing patches in previous 3 months Concurrent skin disease in the study area Immunocompromise Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitiligo Patients on Tildrakizumab<br> | Drug: Tildrakizumab<br>* 2 100mg subcutaneous injections Q4W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tildrakizumab, non-segmental vitiligo, interleukin-23, IL-23, biological treatment, pilot study, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Vitiligo