ZASOCITINIB for Non-segmental vitiligo | Vitiligo

Inclusion criteria

• {"criterion_text":"- 1.Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI ≥0.5 and 5≤ T-VASI ≤50 at screening and Day 1."}
• {"criterion_text":"- 2.Participant is aged ≥18 years to ≤75 years old at the time of consent."}
• {"criterion_text":"- 3.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, if sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who 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 EU/EEA and the 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."}
• {"criterion_text":"- 4.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 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)."}
• {"criterion_text":"- 5.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."}
• {"criterion_text":"- 6.Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures."}

Exclusion criteria

• {"criterion_text":"- 1.Participant has segmental vitiligo"}
• {"criterion_text":"- 10.Non-herpetic viral diseases: a) Participant has presence of HCV antibody and a positive confirmatory test result for HCV 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 PCR testing, HCV RNA PCR testing will be assessed at additional visits per SoA. b) Participant has presence of positive HBsAg, or indeterminate HBsAg, presence of HBV DNA (regardless of serology), or positive anti-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. c) Participant has positive results for HIV by serology, regardless of viral load."}
• {"criterion_text":"- 11.Other infectious diseases: a) Participant has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator. b) Participant has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1. c) 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. d) 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). e) 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. f) Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). g) Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment."}
• {"criterion_text":"- 12.Exclusion Criteria 12 excludes participants with recent or chronic infection history that may present a safety risk. This includes acute or recent infections (e.g., any infection or febrile illness within 7 days, systemic illness within 30 days, or serious infections within 8 weeks of Day 1), as well as any history of chronic or opportunistic infections. See protocol for the full list and detailed definitions of infection-related exclusions."}
• {"criterion_text":"- 13.Participant has any of the following laboratory values at the screening visit, in addition to others listed in the protocol: a) AST or ALT values ≥3 times the ULN. b) Total bilirubin (unconjugated and/or conjugated) ˃1.5 times the ULN. c) Hgb <9.0 g/dL (<90.0 g/L). d) Absolute white blood cell count <3.0 × 109/L (<3000/mm3). e) Absolute neutrophil count of <1.0 × 109/L (<1000/mm3). f) Absolute lymphocyte count of <0.5 × 109/L (<500/mm3). g) Platelet count <100 × 109/L (<100,000/mm3). h) TSH outside the normal reference range AND free T4 or T3 outside the normal reference range. i) Estimated creatinine clearance <30 mL/min based on the Cockcroft-Gault calculation. j) CPK > ULN. CPK may be repeated once; if repeat value is 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 modulating factors including concomitant medications or vigorous exercise that may affect CPK levels."}
• {"criterion_text":"- 14.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."}
• {"criterion_text":"- 15.Participant does not tolerate venipuncture or inability to be venipunctured."}
• {"criterion_text":"- 16.Participant has a history of significant drug allergy (such as anaphylaxis)."}
• {"criterion_text":"- 17.Participant has a known or suspected allergy to zasocitinib or any of its components."}
• {"criterion_text":"- 18.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."}
• {"criterion_text":"- 19.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."}
• {"criterion_text":"- 2.Participant has >50% leukotrichia on the face or >50% leukotrichia of the body (includes the face)."}
• {"criterion_text":"- 20.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."}
• {"criterion_text":"- 21.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."}
• {"criterion_text":"- 3.Participant has a history of phototherapy within 8 weeks before Day 1 including, but not limited to, broadband UV-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before Day 1."}
• {"criterion_text":"- 4.Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments."}
• {"criterion_text":"- 5.History of any depigmenting or bleaching treatment for vitiligo or other skin disorder (for example, monobenzone or phenol)."}
• {"criterion_text":"- 6.History of any surgical treatments for vitiligo."}
• {"criterion_text":"- 7.History of recent or progressive undiagnosed hearing loss."}
• {"criterion_text":"- 8.TB: a) Participant has history of active TB infection, regardless of treatment status. b) 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. c) Participant has evidence of LTBI as evidenced by a positive 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). Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with zasocitinib, rifampin should not be used. For isoniazid monotherapy, a minimum of 6 months should be used. TB testing should be conducted using QuantiFERON-TB Gold submitted to central laboratory unless alternate or additional tests are required per local guidelines. See Appendix 13.4 for country specific requirements. d) Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest 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."}
• {"criterion_text":"- 9.Herpes infections: a) 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. b) 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)."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants achieving ≥75% improvement from baseline in F-VASI at Week 24.","definition_or_measurement_approach":"F-VASI (Facial Vitiligo Area Scoring Index) measured at baseline and Week 24; primary endpoint is proportion of participants with ≥75% improvement from baseline at Week 24."}

Secondary endpoints

• {"endpoint_text":"- Percent change from baseline in the F-VASI at Week 24","definition_or_measurement_approach":"Percent change in F-VASI from baseline to Week 24."}
• {"endpoint_text":"- Percent change from baseline in the T-VASI at Week 24","definition_or_measurement_approach":"Percent change in T-VASI (Total VASI) from baseline to Week 24."}
• {"endpoint_text":"- Proportion of participants achieving ≥50% improvement from baseline in F-VASI at Week 24","definition_or_measurement_approach":"Proportion of participants with ≥50% improvement in F-VASI at Week 24 versus baseline."}
• {"endpoint_text":"- Proportion of participants achieving ≥50% improvement from baseline in T-VASI at Week 24","definition_or_measurement_approach":"Proportion of participants with ≥50% improvement in T-VASI at Week 24 versus baseline."}

Methods

• France: digital waiting room messaging, doctor-to-patient email, recruitment posters and brochures, recruitment procedure documents (country-specific K1/K2 materials).
• Italy: advocacy emails, database and patient messaging, doctor-to-patient email, digital waiting room messaging, search ads, social media video scripts, animated website header storyboard, landing page and other digital ad visuals (country-specific K2/K1 materials).
• Poland: recruitment posters, doctor-to-patient e-mails, master pre-screening scripts, flyers, social media (Instagram), search ads, digital waiting room messaging, landing page, digital ads and advocacy messages (country-specific K1/K2 materials).
• Spain: recruitment procedure, doctor-to-patient email, recruitment poster and brochure and other K1/K2 digital materials.

France

Earliest CTIS Part Ii Submission Date

17-12-2025

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

2

Number Of Sites

6

Number Of Participants

32

Italy

Earliest CTIS Part Ii Submission Date

19-09-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

94

Number Of Sites

4

Number Of Participants

26

Poland

Earliest CTIS Part Ii Submission Date

15-12-2025

Latest Decision Or Authorization Date

04-01-2026

Processing Time Days

20

Number Of Sites

8

Number Of Participants

58

Spain

Earliest CTIS Part Ii Submission Date

28-11-2025

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

46

Number Of Sites

6

Number Of Participants

28

Primary sponsor

Full Name

Takeda Development Center Americas Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 1,11,12,13,14,5,8

Name

PPD Global Central Labs

Responsibilities

Central laboratory responsibilities; sponsorDuties codes: 4,5

Name

QPS LLC

Responsibilities

Laboratory/operational support; sponsorDuties codes: 4,5

Name

Signant Health Global LLC

Responsibilities

eCOA/eConsent and related services; sponsorDuties codes: 5,7

Name

WCG Clinical Inc.

Responsibilities

ClinROs Rater Training; sponsorDuties codes: 15,5,7

Name

Almac Clinical Services LLC

Responsibilities

Supply/logistics; sponsorDuties codes: 14,5

Name

Eresearchtechnology Inc.

Responsibilities

Imaging/data services; sponsorDuties codes: 13,5,7,8

Third parties

• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 13,5,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment; sponsorDuties code: 5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3,5,7","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties codes: 4,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ClinROs Rater Training; sponsorDuties codes: 15,5,7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 14,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CTMS; sponsorDuties codes: 15,5,6,7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"sponsorDuties codes: 4,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Compensation; sponsorDuties code: 15,5","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,11,12,13,14,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 5,7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"sponsorDuties codes: 13, Medical Photographs (value), 5","organisation_type":"Pharmaceutical company"}