A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

NCT07108283 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: TAK-279-VT-20012025-522309-40-00jRCT2031250527
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 70

Brief 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

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving >= 75% Improvement From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24

  The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement. This is recorded as either Yes (achieved \>= 75% improvement) or No (did not achieve).

  Baseline, Week 24

Secondary Outcomes (4)

• Percent Change From Baseline in the F-VASI at Week 24

  Baseline, Week 24

• Percent Change From Baseline in the Total- Vitiligo Area Scoring Index (T-VASI) at Week 24

  Baseline, Week 24

• Percentage of Participants Achieving F-VASI 50 at Week 24

  At Week 24

• Percentage of Participants Achieving T-VASI 50 at Week 24

  At Week 24

Study Arms (5)

Zasocitinib Low Dose

EXPERIMENTAL

Participants will receive Zasocitinib capsules, low dose, orally, up to Week 52.

Drug: Zasocitinib

Zasocitinib Medium Dose

EXPERIMENTAL

Participants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.

Drug: Zasocitinib

Zasocitinib High Dose

EXPERIMENTAL

Participants will receive Zasocitinib capsules, high dose, orally, up to Week 52.

Drug: Zasocitinib

Placebo Group 1/ Zasocitinib Medium Dose

EXPERIMENTAL

Participants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.

Drug: Zasocitinib; Other: Placebo

Placebo Group 2/ Zasocitinib High Dose

EXPERIMENTAL

Participants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.

Drug: Zasocitinib; Other: Placebo

Interventions

Zasocitinib DRUG

Zasocitinib capsules.

Also known as: TAK-279

Placebo Group 1/ Zasocitinib Medium Dose; Placebo Group 2/ Zasocitinib High Dose; Zasocitinib High Dose; Zasocitinib Low Dose; Zasocitinib Medium Dose

Placebo OTHER

Zasocitinib matching placebo capsules.

Placebo Group 1/ Zasocitinib Medium Dose; Placebo Group 2/ Zasocitinib High Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant willingness:
• Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
• Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.
• Disease Characteristics:
• Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (\>=) 0.5 and a T-VASI \>= 5 and less than or equal to (\<=) 50 at screening and Day 1.
• Age and Reproductive Status:
• Participant is aged \>=18 years to \<=75 years old at the time of consent.
• Participant meets the following birth control requirement:
• For participants in the EU/EEA or UK, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March 2023 on measures to minimize risk of serious side effects with Janus Kinase inhibitor (JAKi) (EMA/142279/2023) and the UK MHRA guideline on JAKi: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023 (Drug Safety Update volume 16, issue 9).

You may not qualify if:

• Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that could interfere with the diagnosis or assessment of nonsegmental vitiligo.
• Participant has \>50 percent (%) leukotrichia on the face or \>50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.
• Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (for example, inflammatory bowel disease).
• Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet \[UV\]-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before Day 1. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
• Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
• History of any depigmenting or bleaching treatment for vitiligo or other skin disorder (for example, monobenzone or phenol).
• History of any surgical treatments for vitiligo.
• History of recent or progressive undiagnosed hearing loss.
• Tuberculosis (TB):
• Participant has history of active TB infection, regardless of treatment status.
• Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.
• Participant has evidence of Latent Tuberculosis Infection (LTBI) as evidenced by a positive QuantiFERON (QFT) result OR 2 indeterminate QFT results and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Participant remains eligible if there are no signs/symptoms of active TB AND documentation of no history of active TB can be provided AND (1) participant can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) or (2) participant has a positive QFT result or 2 indeterminate QFT results but has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU/ EEA and the UK, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist).
• Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest Computed Tomography (CT), magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QuantiFERON-TB Gold results unless the participant has had normal chest imaging in the 6 months prior to screening. CT imaging is allowed per local sites requirements.
• Herpes infections:
• Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (70)

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

RECRUITING

First OC Dermatology

Fountain Valley, California, 92708, United States

RECRUITING

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

RECRUITING

The Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

RECRUITING

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

RECRUITING

Therapeutics Clinical Research

San Diego, California, 92123, United States

RECRUITING

Encore Medical Research of Boynton Beach LLC.

Boynton Beach, Florida, 33436, United States

RECRUITING

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

RECRUITING

Advanced Clinical Research Institute (ACRI)

Tampa, Florida, 33607, United States

RECRUITING

Encore Medical Research of Weston LLC

Weston, Florida, 03331, United States

RECRUITING

DelRicht Research - Dermatology

Baton Rouge, Louisiana, 70809, United States

RECRUITING

DelRicht Research (Audubon Dermatology)

New Orleans, Louisiana, 70115, United States

RECRUITING

Lawrence J Green LLC

Rockville, Maryland, 20850, United States

RECRUITING

Hamzavi Dermatology - Canton

Canton, Michigan, 48187, United States

RECRUITING

Mount Sinai

New York, New York, 10028, United States

WITHDRAWN

Weill Cornell Medicine

New York, New York, 10075, United States

RECRUITING

Markowitz Medical dba Optiskin

New York, New York, 10128, United States

RECRUITING

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

Bexley, Ohio, 43209, United States

WITHDRAWN

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

UT Health Science Center Houston

Bellaire, Texas, 77401, United States

RECRUITING

ACRC Trials

Plano, Texas, 75024, United States

RECRUITING

Progressive Clinical Research-San Antonio

San Antonio, Texas, 78213, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Brunswick Dermatology Center (BDC)

Fredericton, New Brunswick, E3B 1G9, Canada

RECRUITING

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

RECRUITING

LEADER research

Hamilton, Ontario, L8L 3C3, Canada

RECRUITING

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

RECRUITING

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

RECRUITING

North York Research Inc

Toronto, Ontario, M2N 3A6, Canada

RECRUITING

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, G1V 4X7, Canada

RECRUITING

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

RECRUITING

The First Hospital of Wuhan

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 100176, China

NOT YET RECRUITING

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

The First Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Bordeaux University Hospital

Bordeaux, 33000, France

NOT YET RECRUITING

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

Créteil, 94010, France

NOT YET RECRUITING

Centre Hospitalier Le Mans (CHM)

Le Mans, 72000, France

NOT YET RECRUITING

Cabinet Medical du Dr Ruer

Martigues, 13500, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital l'Archet

Nice, 6202, France

NOT YET RECRUITING

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Larrey

Toulouse, 31059, France

NOT YET RECRUITING

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

NOT YET RECRUITING

Istituto Dermopatico Immacolata IDI, IRCCS

Rome, Roma, 00167, Italy

NOT YET RECRUITING

Spedali Civili Hospital

Brescia, 25123, Italy

NOT YET RECRUITING

Azienda Usl Toscana Centro

Florence, 50125, Italy

NOT YET RECRUITING

Fondazione Policlinico A. Gemelli

Rome, 00168, Italy

NOT YET RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Toho University-Sakura Hospital Medical Center

Sakura-shi, Chiba, 285-8741, Japan

RECRUITING

Kume Clinic - Sakai

Nishi-ku, Osaka, 593-8324, Japan

RECRUITING

Tokyo Medical University Hospital

Tokyo, TAkyA, 160-0023, Japan

RECRUITING

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

CRI Centro Regiomontano de Investigation SC

Monterrey, New Leon, 64060, Mexico

NOT YET RECRUITING

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, 64460, Mexico

NOT YET RECRUITING

Clinica de Enfermedades Cronicas y de Procedimientos Especiales

Morelia, Predeterminado, 58249, Mexico

NOT YET RECRUITING

Arke SMO SA de CV

Veracruz, 91900, Mexico

NOT YET RECRUITING

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski

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

RECRUITING

dermMedica Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

RECRUITING

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

Szczecin, West Pomeranian Voivodeship, 71-212, Poland

RECRUITING

Gyncentrum Sp. z o.o.

Katowice, 40-600, Poland

RECRUITING

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

Rzeszów, 35-055, Poland

NOT YET RECRUITING

ETG Warszawa

Warsaw, 02-677, Poland

RECRUITING

Dermoklinika Centrum Medyczne

Lodz, Łódź Voivodeship, 90-436, Poland

RECRUITING

Dermedic Jacek Zdybski

Kielce, Świętokrzyskie Voivodeship, 25-553, Poland

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrin

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

NOT YET RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Madrid, 28027, Spain

RECRUITING

Hospital Universitario La Paz (HULP)

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital de Manises

Valencia, 46005, Spain

NOT YET RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 7, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): November 9, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CA (8); IT (5); FR (6); CN (5); PL (8); ME (4); ES (6); US (23); JP (5)