An Early Phase 1 interventional study of Tildrakizumab in Skin and Connective Tissue Diseases, Skin Diseases and Pigmentation Disorder, sponsored by Premier Specialists, Australia. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Premier Specialists, Australia · Early Phase 1, Interventional, and Treatment
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.
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Premier Specialists, Australia is the lead sponsor of 7 studies on the registry; none are open to participants now.
Compared within Vitiligo, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Skin and Connective Tissue Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tildrakizumab
2 100mg subcutaneous injections Q4W
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
Time frame: 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
Time frame: Week 24
Percentage repigmentation: Photographs
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Time frame: Week 24
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
Time frame: Week 12
Percentage repigmentation: Vitiligo Extent Score (VES)
Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse
Time frame: Week 12
Percentage repigmentation: Photographs
Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline.
Time frame: Week 12
Time to repigmentation
Time frame: through study treatment completion at 24-weeks
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
Time frame: 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)
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
Time frame: 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)
Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse.
Time frame: Baseline through week 12 and through study treatment completion at 24-weeks
Adverse events
incidence and nature of any adverse events
Time frame: through study treatment completion at 24-weeks
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tildrakizumab
Premier Specialists, Australia