Biologic, Hypopigmentation, Pigmentation Disorder, Skin and Connective Tissue Diseases, Skin Diseases, Vitiligo
Conditions
Keywords
Tildrakizumab, non-segmental vitiligo, interleukin-23, IL-23, biological treatment, pilot study, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Vitiligo
Brief summary
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
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.
Interventions
DRUGTildrakizumab
2 100mg subcutaneous injections Q4W
Sponsors
Premier Specialists, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage repigmentation: Vitiligo Area Scoring Index (VASI) | Week 24 | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse |
| Percentage repigmentation: Vitiligo Extent Score (VES) | Week 24 | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse |
| Percentage repigmentation: Photographs | Week 24 | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to repigmentation | through study treatment completion at 24-weeks | — |
| Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI) | Baseline through week 12 and through study treatment completion at 24-weeks | Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse |
| Percentage repigmentation: Vitiligo Area Scoring Index (VASI) | Week 12 | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse |
| Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES) | Baseline through week 12 and through study treatment completion at 24-weeks | Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse. |
| Adverse events | through study treatment completion at 24-weeks | incidence and nature of any adverse events |
| Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC) | Baseline through week 12 and through study treatment completion at 24-weeks | 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 |
| Percentage repigmentation: Vitiligo Extent Score (VES) | Week 12 | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse |
| Percentage repigmentation: Photographs | Week 12 | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. |
Countries
Australia
Outcome results
None listed