Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07108283

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

Led by Takeda · Updated on 2026-05-13

200

Participants Needed

70

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to understand and comply with trial procedures including use of digital tools
  • Provided written informed consent before starting trial procedures
  • Clinical diagnosis of nonsegmental vitiligo with F-VASI ≥ 0.5 and T-VASI between 5 and 50 at screening and Day 1
  • Aged between 18 and 75 years at consent
  • For those with potential for pregnancy, use of highly effective contraception or confirmed nonchildbearing status
  • In EU/EEA/UK, no investigator concerns about risk related to Janus Kinase inhibitor use per guidelines
Not Eligible

You will not qualify if you...

  • Segmental vitiligo or other causes of hypopigmentation interfering with diagnosis
  • More than 50% leukotrichia on face or body affected by vitiligo
  • Need for immunomodulatory or immunosuppressive systemic treatment during trial, except NSAIDs
  • Phototherapy within 8 weeks before Day 1
  • Comorbid skin conditions interfering with assessments
  • History of depigmenting, bleaching, or surgical treatments for vitiligo
  • Recent or progressive undiagnosed hearing loss
  • History or signs of active tuberculosis or latent TB without proper prophylaxis
  • Active or severe herpes infections
  • Positive hepatitis B or C or HIV infection
  • Recent or serious infections requiring hospitalization or IV therapy
  • Serious medical conditions or unstable clinical status that pose risk
  • History of immunodeficiency or unstable autoimmune diseases
  • Major surgery within 60 days before Day 1 or planned during trial
  • Uncontrolled hypertension or severe heart failure
  • Significant ECG abnormalities
  • History of suicide attempts or active suicidal ideation
  • Drug or alcohol abuse within 12 months prior to Day 1
  • Abnormal laboratory values beyond specified thresholds
  • Intolerance to venipuncture
  • History of significant drug allergy or allergy to zasocitinib
  • Positive pregnancy test or plans to become pregnant or lactate during trial
  • Blood or plasma donation within 30 days before screening or planned during trial
  • Detainment or institutionalization by judicial or administrative order
  • Trial site employee or dependent of such involved in trial conduct
  • History of rhabdomyolysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 70 locations

1

Dermatology Trial Associates

Bryant, Arkansas, United States, 72022

Actively Recruiting

2

First OC Dermatology

Fountain Valley, California, United States, 92708

Actively Recruiting

3

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States, 94538

Actively Recruiting

4

The Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, United States, 90036

Actively Recruiting

5

UC Davis Department of Dermatology

Sacramento, California, United States, 95816

Actively Recruiting

6

Therapeutics Clinical Research

San Diego, California, United States, 92123

Actively Recruiting

7

Encore Medical Research of Boynton Beach LLC.

Boynton Beach, Florida, United States, 33436

Actively Recruiting

8

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States, 33014

Actively Recruiting

9

Advanced Clinical Research Institute (ACRI)

Tampa, Florida, United States, 33607

Actively Recruiting

10

Encore Medical Research of Weston LLC

Weston, Florida, United States, 03331

Actively Recruiting

11

DelRicht Research - Dermatology

Baton Rouge, Louisiana, United States, 70809

Actively Recruiting

12

DelRicht Research (Audubon Dermatology)

New Orleans, Louisiana, United States, 70115

Actively Recruiting

13

Lawrence J Green LLC

Rockville, Maryland, United States, 20850

Actively Recruiting

14

Hamzavi Dermatology - Canton

Canton, Michigan, United States, 48187

Actively Recruiting

15

Mount Sinai

New York, New York, United States, 10028

Withdrawn

16

Weill Cornell Medicine

New York, New York, United States, 10075

Actively Recruiting

17

Markowitz Medical dba Optiskin

New York, New York, United States, 10128

Actively Recruiting

18

Bexley Dermatology (legal entity - Dermatologists of Southwestern Ohio, LLC)

Bexley, Ohio, United States, 43209

Withdrawn

19

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

20

UT Health Science Center Houston

Bellaire, Texas, United States, 77401

Actively Recruiting

21

ACRC Trials

Plano, Texas, United States, 75024

Actively Recruiting

22

Progressive Clinical Research-San Antonio

San Antonio, Texas, United States, 78213

Actively Recruiting

23

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

24

Brunswick Dermatology Center (BDC)

Fredericton, New Brunswick, Canada, E3B 1G9

Actively Recruiting

25

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada, L4M 7G1

Actively Recruiting

26

LEADER research

Hamilton, Ontario, Canada, L8L 3C3

Actively Recruiting

27

The Centre for Clinical Trials

Oakville, Ontario, Canada, L6J 7W5

Actively Recruiting

28

SKiN Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

Actively Recruiting

29

North York Research Inc

Toronto, Ontario, Canada, M2N 3A6

Actively Recruiting

30

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, Canada, G1V 4X7

Actively Recruiting

31

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada, S7K 2C1

Actively Recruiting

32

The First Hospital of Wuhan

Wuhan, Hubei, China, 430022

Not Yet Recruiting

33

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China, 100176

Not Yet Recruiting

34

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

35

The First Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, China, 650032

Not Yet Recruiting

36

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China, 310009

Not Yet Recruiting

37

Bordeaux University Hospital

Bordeaux, France, 33000

Not Yet Recruiting

38

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor)

Créteil, France, 94010

Not Yet Recruiting

39

Centre Hospitalier Le Mans (CHM)

Le Mans, France, 72000

Not Yet Recruiting

40

Cabinet Medical du Dr Ruer

Martigues, France, 13500

Not Yet Recruiting

41

Centre Hospitalier Universitaire de Nice - Hopital l'Archet

Nice, France, 6202

Not Yet Recruiting

42

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Larrey

Toulouse, France, 31059

Not Yet Recruiting

43

Humanitas Research Hospital

Rozzano, Milan, Italy, 20089

Not Yet Recruiting

44

Istituto Dermopatico Immacolata IDI, IRCCS

Rome, Roma, Italy, 00167

Not Yet Recruiting

45

Spedali Civili Hospital

Brescia, Italy, 25123

Not Yet Recruiting

46

Azienda Usl Toscana Centro

Florence, Italy, 50125

Not Yet Recruiting

47

Fondazione Policlinico A. Gemelli

Rome, Italy, 00168

Actively Recruiting

48

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan, 467-8602

Actively Recruiting

49

Toho University-Sakura Hospital Medical Center

Sakura-shi, Chiba, Japan, 285-8741

Actively Recruiting

50

Kume Clinic - Sakai

Nishi-ku, Osaka, Japan, 593-8324

Actively Recruiting

51

Tokyo Medical University Hospital

Tokyo, TAkyA, Japan, 160-0023

Actively Recruiting

52

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan, 113-8603

Actively Recruiting

53

CRI Centro Regiomontano de Investigation SC

Monterrey, New Leon, Mexico, 64060

Not Yet Recruiting

54

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, Mexico, 64460

Not Yet Recruiting

55

Clinica de Enfermedades Cronicas y de Procedimientos Especiales

Morelia, Predeterminado, Mexico, 58249

Not Yet Recruiting

56

Arke SMO SA de CV

Veracruz, Mexico, 91900

Not Yet Recruiting

57

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski

Osielsko, Kuyavian-Pomeranian Voivodeship, Poland, 86-031

Actively Recruiting

58

dermMedica Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, Poland, 51-503

Actively Recruiting

59

Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

Szczecin, West Pomeranian Voivodeship, Poland, 71-212

Actively Recruiting

60

Gyncentrum Sp. z o.o.

Katowice, Poland, 40-600

Actively Recruiting

61

Klinika Dermatologii i Dermatologii Onkologicznej Uniw. Szp. Klin. in Rzeszow

Rzeszów, Poland, 35-055

Actively Recruiting

62

ETG Warszawa

Warsaw, Poland, 02-677

Actively Recruiting

63

Dermoklinika Centrum Medyczne

Lodz, Łódź Voivodeship, Poland, 90-436

Actively Recruiting

64

Dermedic Jacek Zdybski

Kielce, Świętokrzyskie Voivodeship, Poland, 25-553

Actively Recruiting

65

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Las Palmas, Spain, 35010

Not Yet Recruiting

66

Hospital Universitario Reina Sofia

Córdoba, Spain, 14004

Not Yet Recruiting

67

Clinica Universidad de Navarra

Madrid, Spain, 28027

Actively Recruiting

68

Hospital Universitario La Paz (HULP)

Madrid, Spain, 28034

Actively Recruiting

69

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

70

Hospital de Manises

Valencia, Spain, 46005

Not Yet Recruiting

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Research Team

T

Takeda Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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