drugset / Trial / NCT04971200
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-09-16
- Primary completion
- 2024-11-10
- Completion
- 2024-11-10
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tildrakizumab | Monoclonal antibody | 200 mg | Subcutaneous |