Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

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

  • Drug: Tildrakizumab
    • 2 100mg subcutaneous injections Q4W

Arms, Groups and Cohorts

  • Experimental: Vitiligo Patients on Tildrakizumab

Clinical Trial Outcome Measures

Primary Measures

  • Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
    • Time Frame: 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)
    • Time Frame: Week 24
    • Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
  • Percentage repigmentation: Photographs
    • Time Frame: Week 24
    • Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.

Secondary Measures

  • Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
    • Time Frame: 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)
    • Time Frame: Week 12
    • Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
  • Percentage repigmentation: Photographs
    • Time Frame: Week 12
    • Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
  • Time to repigmentation
    • Time Frame: through study treatment completion at 24-weeks
  • Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: through study treatment completion at 24-weeks
    • incidence and nature of any adverse events

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Premier Specialists, Australia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dedee Murrell, MD, Principal Investigator, University of New South Wales
  • Overall Contact(s)
    • Dedee Murrell, MD, 9598 5800, d.murrell@unsw.edu.au

References

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.

Vaccaro M, Cannavò 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.

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.

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.

van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taïeb 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.

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.

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.

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