AzTrials
AzTrials

Skin and Connective Tissue DiseasesEarly Phase 1TILDVIT-1227NCT04971200

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

A Early Phase 1 study testing Tildrakizumab in people with Skin and Connective Tissue Diseases and Skin Diseases, run by Premier Specialists, Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tildrakizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustralia
Study dates
16 Sep 2021to 10 Nov 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Premier Specialists Pty Ltd

    Sydney, New South Wales, 2217

Other trials in Australia

About this study

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.

Read the 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.

Being tested
Tildrakizumab
Keywords
Tildrakizumab, non-segmental vitiligo, interleukin-23, IL-23, biological treatment, pilot study, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Vitiligo
Medical subject headings
Skin and Connective Tissue Diseases, Skin Diseases, Pigmentation Disorders, Hypopigmentation, Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TildrakizumabDrug

    2 100mg subcutaneous injections Q4W

Study groups in NCT04971200
Study groupRoleWhat they receive
Vitiligo Patients on TildrakizumabExperimentalNot described
Receives: Drug: Tildrakizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 24

  2. Percentage repigmentation: Vitiligo Extent Score (VES)

    Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse

    Measured: Week 24

  3. Percentage repigmentation: Photographs

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

    Measured: Week 24

Secondary outcomes (8)

  1. 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

    Measured: Week 12

  2. Percentage repigmentation: Vitiligo Extent Score (VES)

    Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse

    Measured: Week 12

  3. Percentage repigmentation: Photographs

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

    Measured: Week 12

  4. Time to repigmentation

    Measured: through study treatment completion at 24-weeks

  5. Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)

    Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse

    Measured: Baseline through week 12 and through study treatment completion at 24-weeks

  6. Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC)

    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

    Measured: Baseline through week 12 and through study treatment completion at 24-weeks

  7. Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES)

    Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse.

    Measured: Baseline through week 12 and through study treatment completion at 24-weeks

  8. Adverse events

    incidence and nature of any adverse events

    Measured: through study treatment completion at 24-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start16 Sep 2021
  3. Primary completion10 Nov 2024
  4. Study completion10 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04971200
Sponsor's protocol ID
2021-04-373
Acronym
TILDVIT-1227
Status last verified
Nov 2024
First submitted
1 Jul 2021
Last updated
12 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 32441048

  • 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.

    PubMed 25427848

  • 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.

    PubMed 31172649

  • 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.

    PubMed 15210457

  • 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.

    PubMed 26827762

  • 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.

    PubMed 8033378

  • 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.

    PubMed 27887798

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tildrakizumab in people with Skin and Connective Tissue Diseases and Skin Diseases, run by Premier Specialists, Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage repigmentation: Vitiligo Area Scoring Index (VASI) (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971200, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in