Clinical trial NCT04971200: Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Official title: Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Skin and Connective Tissue Diseases
Skin Diseases
Pigmentation Disorder
Hypopigmentation
Biologic
Vitiligo
Keywords: Tildrakizumab
non-segmental vitiligo
interleukin-23
IL-23
biological treatment
pilot study
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Vitiligo
Lead sponsor: Premier Specialists, Australia
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
timeFrame: Week 24
measure: Percentage repigmentation: Vitiligo Extent Score (VES)
timeFrame: Week 24
measure: Percentage repigmentation: Photographs
timeFrame: Week 24
Secondary outcomes:
measure: Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
timeFrame: Week 12
measure: Percentage repigmentation: Vitiligo Extent Score (VES)
timeFrame: Week 12
measure: Percentage repigmentation: Photographs
timeFrame: Week 12
measure: Time to repigmentation
timeFrame: through study treatment completion at 24-weeks
measure: Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline through week 12 and through study treatment completion at 24-weeks
measure: Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC)
timeFrame: Baseline through week 12 and through study treatment completion at 24-weeks
measure: Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES)
timeFrame: Baseline through week 12 and through study treatment completion at 24-weeks
measure: Adverse events
timeFrame: through study treatment completion at 24-weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Dedee Murrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.