Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Vitiligo Clinical Trial

— TILDVIT-1227  

Official title:

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04971200
• Other study ID #: 2021-04-373
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 16, 2021
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Premier Specialists, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Hypopigmentation
• Pigmentation Disorder
• Pigmentation Disorders
• Skin and Connective Tissue Diseases
• Skin Diseases
• Vitiligo

Intervention

Drug:
• Tildrakizumab
2 100mg subcutaneous injections Q4W

Locations

Country	Name	City	State
Australia	Premier Specialists Pty Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Premier Specialists, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage repigmentation: Photographs	Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.	Week 24
Secondary	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
Secondary	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
Secondary	Percentage repigmentation: Photographs	Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.	Week 12
Secondary	Time to repigmentation		through study treatment completion at 24-weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	incidence and nature of any adverse events	through study treatment completion at 24-weeks

External Links

•   Premier Specialists Dermatology