Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo (TILDVIT-1227)

October 5, 2023 updated by: Premier Specialists, Australia
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2217
        • Premier Specialists Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitiligo Patients on Tildrakizumab
Drug: Tildrakizumab
2 100mg subcutaneous injections Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Time Frame: Week 24
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)
Time Frame: Week 24
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Week 24
Percentage repigmentation: Photographs
Time Frame: Week 24
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Time Frame: Week 12
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Week 12
Percentage repigmentation: Vitiligo Extent Score (VES)
Time Frame: Week 12
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Week 12
Percentage repigmentation: Photographs
Time Frame: Week 12
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Week 12
Time to repigmentation
Time Frame: through study treatment completion at 24-weeks
through study treatment completion at 24-weeks
Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI)
Time Frame: Baseline through week 12 and through study treatment completion at 24-weeks
Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse
Baseline through week 12 and through study treatment completion at 24-weeks
Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC)
Time Frame: Baseline through week 12 and through study treatment completion at 24-weeks
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
Baseline through week 12 and through study treatment completion at 24-weeks
Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES)
Time Frame: Baseline through week 12 and through study treatment completion at 24-weeks
Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse.
Baseline through week 12 and through study treatment completion at 24-weeks
Adverse events
Time Frame: through study treatment completion at 24-weeks
incidence and nature of any adverse events
through study treatment completion at 24-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Premier Specialists, Australia

Investigators

  • Principal Investigator: Dedee Murrell, MD, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-04-373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Diseases

Clinical Trials on Tildrakizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe