Trials / Completed
CompletedNCT04971200
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Premier Specialists, Australia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Skin and Connective Tissue Diseases
- Skin Diseases
- Pigmentation Disorder
- Hypopigmentation
- Biologic
- Vitiligo
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tildrakizumab | 2 100mg subcutaneous injections Q4W |
Timeline
- Start date
- 2021-09-16
- Primary completion
- 2024-11-10
- Completion
- 2024-11-10
- First posted
- 2021-07-21
- Last updated
- 2024-11-12
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04971200. Inclusion in this directory is not an endorsement.