Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

NCT04971200 | Completed Early Phase 1

• 1 other identifier: 2021-04-373
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Percentage repigmentation: Photographs

  Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.

  Week 24

Secondary Outcomes (8)

• Percentage repigmentation: Vitiligo Area Scoring Index (VASI)

  Week 12

• Percentage repigmentation: Vitiligo Extent Score (VES)

  Week 12

• Percentage repigmentation: Photographs

  Week 12

• 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

Study Arms (1)

Vitiligo Patients on Tildrakizumab

EXPERIMENTAL

Drug: Tildrakizumab

Interventions

Tildrakizumab DRUG

2 100mg subcutaneous injections Q4W

Vitiligo Patients on Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Premier Specialists, Australia: lead

Study Sites (1)

Premier Specialists Pty Ltd

Sydney, New South Wales, 2217, Australia

Location

Related Publications (7)

• 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.

  PMID: 32441048 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.

  PMID: 25427848 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.

  PMID: 31172649 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.

  PMID: 15210457 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.

  PMID: 26827762 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.

  PMID: 8033378 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.

  PMID: 27887798 BACKGROUND

Related Links

• Premier Specialists Dermatology

MeSH Terms

Conditions

Skin and Connective Tissue Diseases; Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo

Interventions

tildrakizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dedee Murrell, MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 21, 2021
• Study Start: September 16, 2021
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

AU (1)