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Nonsegmental VitiligoPhase 2NCT07108283

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

A Phase 2 study testing Zasocitinib in people with Nonsegmental Vitiligo, run by Takeda at 67 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonsegmental Vitiligo
What is being tested?
Zasocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
67 sitesin 9 countries
Study dates
3 Nov 2025to 9 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • Participant is aged >=18 years to <=75 years old at the time of consent.
  • Participant meets the following birth control requirement:
  • An individual with potential for pregnancy who is now of nonchildbearing potential with laboratory confirmation of postmenopausal status; or an individual with potential for pregnancy who if sexually active with a nonsterilized individual who produces sperm, agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial. The use of effective contraception will be required for assigned male sex at birth participants. In the European Union (EU) / European Economic Area (EEA) and the United Kingdom (UK), for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial at screening and every 3 months during the trial.
  • 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).

Who cannot join

  • Target Disease-Related Exclusions:
  • 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.
Show all 68Show fewer
  • 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.
  • Recent/Concurrent Infectious Disease Exclusions:
  • 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.
  • Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
  • Non-herpetic viral diseases:
  • Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic Acid (RNA) (nucleic acid test or polymerase chain reaction). In the EU/EEA and the UK, if the participant has total anti-HCV antibody positivity at screening but is confirmed to have no detectable HCV RNA by Polymerase Chain Reaction (PCR) testing, HCV RNA PCR testing will be assessed at additional visits per Schedule of Activities (SoA).
  • Participant has presence of positive Hepatitis B surface antigen (HBsAg), or indeterminate HBsAg, presence of Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti- Hepatitis B core antibody (HBcAb) without concurrent positive HBsAb. In the EU/EEA and the UK, if the participant has total anti-HBc antibody positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing at additional visits per SoA; if a participant has anti-HBsAb positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, unless the participant has documented completion of the HBV vaccination series by medical records, the participant will repeat HBV DNA PCR testing at additional visits per SoA. Note: For other countries in which there are hepatitis B screening guidelines, these can be done per local regulations or site's standard of care.
  • Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.
  • Other infectious diseases:
  • Participant has a history of active infection or febrile illness (with or without other symptoms) within 7 days prior to Day 1, as assessed by the investigator.
  • Participant has a history of serious or severe infection within 30 days prior to Day 1, as assessed by the investigator.
  • Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30 days prior to Day 1.
  • Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis).
  • Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.
  • Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
  • Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.
  • Noninfectious Disorders Exclusions:
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurologic, nutritional, ophthalmologic or immunologic), or vital signs/physical/laboratory/Electrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:
  • Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
  • Participant has a history of new or unstable autoimmune disease (including but not limited to thyroid disease, lupus, sjogrens, myasthenia gravis, or rheumatoid arthritis).
  • Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.
  • Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
  • Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
  • Participant has a history of cancer or lymphoproliferative disease with the exception of successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix. In the EU/EEA and the UK, for the participants with a history of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix, investigators must document a favorable benefit-risk assessment.
  • For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1, or participant has been hospitalized within 3 months prior to Day 1.
  • Participant has any of the following cardiovascular disease history:
  • A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.
  • Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator documents there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll; in the EU/EEA and the UK, investigators must document a favorable benefit-risk assessment.
  • Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if they participated in the trial, in the opinion of the investigator.
  • Participant has any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideation with intent and plan based on medical history or a YES response to Columbia-Suicide Severity Rating Scale (C-SSRS) Questions 5; the participant has evidence of current active suicidal ideation based on YES response to questions 2, 3, 4, or 5 on C-SSRS Since Last Visit performed on Day1; or is clinically deemed to have a suicide risk by the investigator.
  • Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
  • Laboratory/Physical Exclusions:
  • Participant has any of the following laboratory values at the screening visit:
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) values >=3 times the Upper Limit of Normal (ULN).
  • Total bilirubin (unconjugated and/or conjugated) ˃1.5 times the ULN.
  • Hemoglobin (Hgb) <9.0 gram/deciliter (g/dL) (<90.0 gram/Liter [g/L]).
  • Absolute white blood cell count less than (<) 3.0 * 10^9/Liter (L) (<3000/cubic millimeter [mm^3]).
  • Absolute neutrophil count of <1.0 * 10^9/L (<1000/mm^3).
  • Absolute lymphocyte count of <0.5 * 10^9/L (<500/mm^3).
  • Platelet count <100 * 10^9/L (<100,000/mm^3).
  • Thyroid Stimulating Hormone (TSH) outside the normal reference range AND free T4 or T3 outside the normal reference range.
  • Estimated creatinine clearance <45 milliliter/minute (mL/min) based on the Cockcroft-Gault calculation.
  • Creatine Phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (or <=2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for symptoms of rhabdomyolysis, and for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.
  • Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
  • Participant does not tolerate venipuncture or inability to be venipunctured.
  • Allergies and Adverse Drug Reactions Exclusions:
  • Participant has a history of significant drug allergy (such as anaphylaxis).
  • Participant has a known or suspected allergy to zasocitinib or any of its components.
  • Other Exclusions:
  • Participant has a positive pregnancy test result or plans to become pregnant during the trial period, including plans to undergo in vitro fertilization, donate ova (eggs), or sperm, or participant is lactating/nursing.
  • Participant has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the course of the trial.
  • Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued either by judicial or administrative authorities.
  • Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with trial site employee who is involved in the conduct of this trial or may consent under duress.
  • History of rhabdomyolysis.

Trial locations and contacts

67 sites in 9 countries.

67 sites in 9 countries

United States21 sites

  • DelRicht Research - Dermatology

    Baton Rouge, Louisiana, 70809

  • UT Health Science Center Houston

    Bellaire, Texas, 77401

  • Encore Medical Research of Boynton Beach LLC.

    Boynton Beach, Florida, 33436

  • Dermatology Trial Associates

    Bryant, Arkansas, 72022

  • Hamzavi Dermatology - Canton

    Canton, Michigan, 48187

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • The Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California, 90036

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • DelRicht Research (Audubon Dermatology)

    New Orleans, Louisiana, 70115

  • Weill Cornell Medicine

    New York, New York, 10075

  • Markowitz Medical dba Optiskin

    New York, New York, 10128

  • ACRC Trials

    Plano, Texas, 75024

  • Lawrence J Green LLC

    Rockville, Maryland, 20850

  • UC Davis Department of Dermatology

    Sacramento, California, 95816

  • Progressive Clinical Research-San Antonio

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • Advanced Clinical Research Institute (ACRI)

    Tampa, Florida, 33607

  • Encore Medical Research of Weston LLC

    Weston, Florida, 03331

Other trials in United States

Canada8 sites

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Brunswick Dermatology Center (BDC)

    Fredericton, New Brunswick, E3B 1G9

  • LEADER research

    Hamilton, Ontario, L8L 3C3

  • The Centre for Clinical Trials

    Oakville, Ontario, L6J 7W5

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique de Quebec

    Québec, Quebec, G1V 4X7

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • North York Research Inc

    Toronto, Ontario, M2N 3A6

Other trials in Canada

Poland8 sites

  • Gyncentrum Sp. z o.o.

    Katowice, 40-600

  • Dermedic Jacek Zdybski

    Kielce, Świętokrzyskie Voivodeship, 25-553

  • Dermoklinika Centrum Medyczne

    Lodz, Łódź Voivodeship, 90-436

  • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

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

    Rzeszów, 35-055

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

    Szczecin, West Pomeranian Voivodeship, 71-212

  • ETG Warszawa

    Warsaw, 02-677

  • dermMedica Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 51-503

Other trials in Poland

France6 sites

  • Bordeaux University Hospital

    Bordeaux, 33000

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

    Créteil, 94010

  • Centre Hospitalier Le Mans (CHM)

    Le Mans, 72000

  • Cabinet Medical du Dr Ruer

    Martigues, 13500

  • Centre Hospitalier Universitaire de Nice - Hopital l'Archet

    Nice, 6202

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Larrey

    Toulouse, 31059

Other trials in France

Spain6 sites

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario La Paz (HULP)

    Madrid, 28034

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital de Manises

    Valencia, 46005

Other trials in Spain

China5 sites

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, 310009

  • The First Affiliated Hospital of Kunming Medical College

    Kunming, Yunnan, 650032

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The First Hospital of Wuhan

    Wuhan, Hubei, 430022

  • First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 100176

Other trials in China

Italy5 sites

  • Spedali Civili Hospital

    Brescia, 25123

  • Azienda Usl Toscana Centro

    Florence, 50125

  • Istituto Dermopatico Immacolata IDI, IRCCS

    Rome, Roma, 00167

  • Fondazione Policlinico A. Gemelli

    Rome, 00168

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

Other trials in Italy

Japan5 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kume Clinic - Sakai

    Nishi-ku, Osaka, 593-8324

  • Toho University-Sakura Hospital Medical Center

    Sakura-shi, Chiba, 285-8741

  • Tokyo Medical University Hospital

    Tokyo, TAkyA, 160-0023

Other trials in Japan

Mexico3 sites

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo León, 64460

  • Clinica de Enfermedades Cronicas y de Procedimientos Especiales

    Morelia, Predeterminado, 58249

  • Arke SMO SA de CV

    Veracruz, 91900

Other trials in Mexico

About this study

Official title: 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

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.

Read more

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.

Being tested
Zasocitinib, Placebo
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZasocitinibDrug

    Also called TAK-279

    Zasocitinib capsules.

  • PlaceboOther

    Zasocitinib matching placebo capsules.

Study groups in NCT07108283
Study groupRoleWhat they receive
Zasocitinib Low DoseExperimentalParticipants will receive Zasocitinib capsules, low dose, orally, up to Week 52.
Receives: Drug: Zasocitinib
Zasocitinib Medium DoseExperimentalParticipants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.
Receives: Drug: Zasocitinib
Zasocitinib High DoseExperimentalParticipants will receive Zasocitinib capsules, high dose, orally, up to Week 52.
Receives: Drug: Zasocitinib
Placebo Group 1/ Zasocitinib Medium DoseExperimentalParticipants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.
Receives: Drug: Zasocitinib; Other: Placebo
Placebo Group 2/ Zasocitinib High DoseExperimentalParticipants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.
Receives: Drug: Zasocitinib; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 24

Secondary outcomes (4)

  1. Percent Change From Baseline in the 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.

    Measured: Baseline, Week 24

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

    The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease.

    Measured: Baseline, Week 24

  3. Percentage of Participants Achieving F-VASI 50 at Week 24

    F-VASI 50 is defined as >=50% improvement from baseline.

    Measured: At Week 24

  4. Percentage of Participants Achieving T-VASI 50 at Week 24

    T-VASI 50 is defined as >=50% improvement from baseline.

    Measured: At Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start3 Nov 2025
  3. Primary completion26 Mar 2027 (estimated)
  4. Study completion9 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108283
Sponsor's protocol ID
TAK-279-VT-2001
Other IDs
2025-522309-40-00, jRCT2031250527, 2025
Status last verified
Nov 2026
First submitted
5 Aug 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zasocitinib in people with Nonsegmental Vitiligo, run by Takeda at 67 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 68 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Canada, Poland, France, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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