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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04971200




Registration number
NCT04971200
Ethics application status
Date submitted
1/07/2021
Date registered
21/07/2021
Date last updated
6/10/2023

Titles & IDs
Public title
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Scientific title
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Secondary ID [1] 0 0
2021-04-373
Universal Trial Number (UTN)
Trial acronym
TILDVIT-1227
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin and Connective Tissue Diseases 0 0
Skin Diseases 0 0
Pigmentation Disorder 0 0
Hypopigmentation 0 0
Biologic 0 0
Vitiligo 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tildrakizumab

Experimental: Vitiligo Patients on Tildrakizumab -


Treatment: Drugs: Tildrakizumab
2 100mg subcutaneous injections Q4W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage repigmentation: Vitiligo Extent Score (VES)
Timepoint [2] 0 0
Week 24
Primary outcome [3] 0 0
Percentage repigmentation: Photographs
Timepoint [3] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage repigmentation: Vitiligo Extent Score (VES)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage repigmentation: Photographs
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Time to repigmentation
Timepoint [4] 0 0
through study treatment completion at 24-weeks
Secondary outcome [5] 0 0
Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)
Timepoint [5] 0 0
Baseline through week 12 and through study treatment completion at 24-weeks
Secondary outcome [6] 0 0
Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC)
Timepoint [6] 0 0
Baseline through week 12 and through study treatment completion at 24-weeks
Secondary outcome [7] 0 0
Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES)
Timepoint [7] 0 0
Baseline through week 12 and through study treatment completion at 24-weeks
Secondary outcome [8] 0 0
Adverse events
Timepoint [8] 0 0
through study treatment completion at 24-weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Premier Specialists, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04971200
Trial related presentations / publications
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.
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.
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. doi: 10.1001/archderm.140.6.677.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dedee Murrell, MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04971200