A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

Conditions

• Nonsegmental Vitiligo

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Zasocitinib — DRUG
  Zasocitinib capsules.
• Placebo — OTHER
  Zasocitinib matching placebo capsules.

Study Details

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.

Key Dates

Start date

Nov 3, 2025

Status verified

May 2026

Primary completion

Oct 12, 2027

Completion

Nov 9, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zasocitinib Low Dose
  Participants will receive Zasocitinib capsules, low dose, orally, up to Week 52.
• Experimental: Zasocitinib Medium Dose
  Participants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.
• Experimental: Zasocitinib High Dose
  Participants will receive Zasocitinib capsules, high dose, orally, up to Week 52.
• Experimental: Placebo Group 1/ Zasocitinib Medium Dose
  Participants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.
• Experimental: Placebo Group 2/ Zasocitinib High Dose
  Participants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.

Primary Outcome Measure

Percentage of Participants Achieving >= 75% Improvement From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (23)

Find similar trials in Bryant, AR

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