Actively Recruiting
A Phase 2 Trial to Evaluate the Safety and Effectiveness of Zasocitinib in Adults With Nonsegmental Vitiligo
Led by Takeda · Updated on 2026-05-13
200
Participants Needed
70
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Vitiligo is a long-term autoimmune condition where the body's immune system attacks skin cells that produce pigment, causing patches without color. This study is focused on adults with nonsegmental vitiligo, where patches appear symmetrically on both sides of the body. Researchers aim to learn how safe and tolerable the drug zasocitinib is, and how well it works for this condition. Participants will be randomly assigned to receive different doses of zasocitinib capsules or a placebo. Those initially on placebo will switch to a medium or high dose of zasocitinib after about six months. The treatment period lasts up to 52 weeks with several dosage groups including low, medium, and high doses of zasocitinib. During the study, participants will visit the clinic 11 times for assessments. Researchers will measure improvements using the Facial Vitiligo Area Scoring Index (F-VASI) and the Total Vitiligo Area Scoring Index (T-VASI). Safety, tolerability, and effectiveness will be monitored throughout the study, with the main outcome assessed at week 24. Participants will be closely followed to track treatment responses and any side effects.
CONDITIONS
Brief Title
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to understand and comply with trial procedures and digital tools.
- Participant has provided written informed consent and privacy authorization.
- 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 the time of consent.
- For those with potential for pregnancy, must use highly effective contraception or be of nonchildbearing potential with lab confirmation.
- Participants in EU/EEA/UK must meet specific safety assessments related to Janus Kinase inhibitors.
You will not qualify if you...
- Segmental vitiligo, mixed vitiligo, or other causes of skin depigmentation interfering with diagnosis.
- More than 50% leukotrichia on the face or body in affected skin.
- Need for systemic immunomodulatory or immunosuppressive treatment during the trial.
- Phototherapy or tanning booth use within 8 weeks before Day 1.
- Comorbid skin conditions interfering with assessments.
- History of depigmenting or bleaching treatments or surgical treatments for vitiligo.
- Recent or active infections including tuberculosis, herpes, hepatitis B or C, HIV.
- Clinically significant unstable medical conditions or abnormal lab values that increase risk.
- History of severe allergies to zasocitinib or its components.
- Pregnancy, lactation, recent blood donation, or plans to donate blood during the trial.
- Being detained or committed by judicial or administrative authorities.
- Trial site employee or family member in dependent relationship with site staff involved in the trial.
- History of rhabdomyolysis or serious suicidal behavior or ideation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive Zasocitinib or placebo capsules orally in different dosing regimens for up to 52 weeks.
Regular visits during treatment period
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
Research Team
T
Takeda 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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