TILDVIT-1227: Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Sponsor

Premier Specialists, Australia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04971200

Collaborator

(none)

Enrollment

Location

Arm

21.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin and Connective Tissue Diseases Skin Diseases Pigmentation Disorder Hypopigmentation Biologic Vitiligo	Drug: Tildrakizumab	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Actual Study Start Date :

Sep 16, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitiligo Patients on Tildrakizumab	Drug: Tildrakizumab 2 100mg subcutaneous injections Q4W

Arm

Intervention/Treatment

Experimental: Vitiligo Patients on Tildrakizumab

Drug: Tildrakizumab

2 100mg subcutaneous injections Q4W

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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.
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.