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

Premier Specialists, Australia

Status and phase

Completed

Early Phase 1

Conditions

Pigmentation Disorder

Vitiligo

Hypopigmentation

Skin and Connective Tissue Diseases

Biologic

Skin Diseases

Treatments

Drug: Tildrakizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04971200

2021-04-373

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.