NCT07108283

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants With Nonsegmental Vitiligo

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches). The main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo. The participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months. During the study, participants will visit their study clinic 11 times.

Conditions

• Nonsegmental Vitiligo

Interventions

Type	Name	Description
DRUG	Zasocitinib	Zasocitinib capsules.
OTHER	Placebo	Zasocitinib matching placebo capsules.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-10-12
• Completion: 2027-11-09
• First posted: 2025-08-07
• Last updated: 2026-04-08

Locations

70 sites across 9 countries: United States, Canada, China, France, Italy, Japan, Mexico, Poland, Spain

Regulatory

• FDA-regulated drug study