Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

  • STATUS
    Recruiting
  • End date
    Jun 8, 2022
  • participants needed
    12
  • sponsor
    Premier Specialists, Australia
Updated on 8 August 2021
hypopigmentation

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.

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.

Details
Condition Leukoderma, Biological Products, Pigmentation Disorders, Skin and Connective Tissue Diseases, Biology, Dermatosis, Vitiligo, Skin Condition, Skin Conditions, skin disorder, depigmentation, hypopigmentation, skin disease, skin disorders, dermatological disease, disease skin, skin diseases, dermatological diseases, dermatoses, biologic agent, biological factors, biologic agents, biologics, biopharmaceutical, factors, biological, biological drug, biopharmaceuticals, disorder of pigmentation
Treatment Tildrakizumab
Clinical Study IdentifierNCT04971200
SponsorPremier Specialists, Australia
Last Modified on8 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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