A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

May 7, 2026 updated by: Takeda

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it.

The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children.

At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib.

Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study.

Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Wenhui Wang
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Principal Investigator:
          • Jinhua Xu
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100045
        • Recruiting
        • Beijing Children Hospital, Capital Medical University
        • Principal Investigator:
          • Zigang Xu
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Not yet recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Xiaohua Wang
    • Hunan
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan Children's Hospital
        • Principal Investigator:
          • Zhu Wei
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
        • Principal Investigator:
          • Liming Wu
        • Contact:
  • Germany
      • Bonn, Germany, 53127
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
        • Principal Investigator:
          • Petra Staubach-Renz
        • Contact:
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Not yet recruiting
        • Johann Wolfgang Goethe-Universität Frankfurt am Main
        • Principal Investigator:
          • Andreas Pinter
        • Contact:
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim
        • Principal Investigator:
          • Athanasios Tsianakas
        • Contact:
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Not yet recruiting
        • Uniklinik Koln, Klinik fur Dermatologie und Venerologie
        • Contact:
        • Principal Investigator:
          • Daniela Neumayer
      • Münster, North Rhine-Westphalia, Germany, 48145
        • Not yet recruiting
        • University Hospital of Muenster
        • Principal Investigator:
          • Nina Magnolo
        • Contact:
  • Italy
      • Padova, Italy, 35121
        • Not yet recruiting
        • Universita Degli Studi Di Padova
        • Contact:
        • Principal Investigator:
          • Anna Belloni Fortina
      • Rome, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Principal Investigator:
          • Ketty Peris
        • Contact:
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Not yet recruiting
        • Presidio Ospedaliero Gaspare Rodolico
        • Principal Investigator:
          • Giuseppe Micali
        • Contact:
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Principal Investigator:
          • Akimichi Morita
        • Contact:
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8555
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan
        • Contact:
        • Principal Investigator:
          • Yuu Sawada
    • Mie-ken
      • Tsu, Mie, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Principal Investigator:
          • Keiichi Yamanaka
        • Contact:
    • Osaka
      • Osaka, Osaka, Japan, 550-0006
    • Tokyo
      • Itabashi-Ku, Tokyo, Japan, 173-0003
        • Recruiting
        • Teikyo University Hospital
        • Contact:
        • Principal Investigator:
          • Yayoi Tada
  • Poland
      • Lodz, Poland, 90-265
        • Not yet recruiting
        • "DERMED" Centrum Medyczne Sp. z o. o.
        • Contact:
        • Principal Investigator:
          • Andrzej Kaszuba
      • Lodz, Poland, 90-436
        • Not yet recruiting
        • Dermoklinika-Centrum Medyczne s.c
        • Principal Investigator:
          • Joanna Narbutt
        • Contact:
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Not yet recruiting
        • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
        • Principal Investigator:
          • Jacek Szepietowski
        • Contact:
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-573
        • Not yet recruiting
        • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
        • Contact:
        • Principal Investigator:
          • Dorota Krasowska
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
        • Principal Investigator:
          • Aleksandra Okuniewska
        • Contact:
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Not yet recruiting
        • Centrum Badan Klinicznych Pi-house Sp. Z O. O.
        • Principal Investigator:
          • Aleksandra Okuniewska
        • Contact:
  • Spain
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital de La Santa Creu i Sant Pau - Dermatologia
        • Contact:
        • Principal Investigator:
          • Anna Lopez Ferrer
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Raquel Rivera-Diaz
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Santiago de Compostela
        • Contact:
        • Principal Investigator:
          • Maria Isabel Rodriguez Blanco
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Exalt Clinical Research
        • Contact:
        • Principal Investigator:
          • Jaqueline McKesey
      • Fountain Valley, California, United States, 92708
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Medical Center
        • Principal Investigator:
          • Frank Don
        • Contact:
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008-3811
        • Recruiting
        • Arlington Dermatology
        • Contact:
        • Principal Investigator:
          • Michael Bukhalo
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Apex Clinical Research Center, LLC
        • Principal Investigator:
          • Jorge Garcia-Zuazaga
        • Contact:
      • Fairborn, Ohio, United States, 45324
        • Recruiting
        • Wright State Physicians
        • Principal Investigator:
          • Craig Rohan
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124-4005
        • Recruiting
        • Apex Clinical Research Center, LLC
        • Contact:
        • Principal Investigator:
          • Jorge Garcia-Zuazaga
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Lara Wine Lee
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Not yet recruiting
        • UT Physicians Dermatology - Bellaire Station
        • Principal Investigator:
          • Adelaide Hebert
        • Contact:
      • San Antonio, Texas, United States, 78218-3128
        • Recruiting
        • Texas Dermatology and Laser Specialists-San Antonio
        • Principal Investigator:
          • John Browning
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Kristen Holland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (>=) 6 months prior to the screening visit.
  2. Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening.
  3. Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score >=12 and a Static Physician's Global Assessment (sPGA) score >=3 at screening and Day 1.
  4. Participant has plaque psoriasis covering >=10 percent (%) of total body surface area (BSA) at screening and Day 1.
  5. Participant must be a candidate for phototherapy or systemic therapy.
  6. Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (<) 18 years, inclusive.
  7. Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to <12 years, inclusive.
  8. Inclusion Criteria for Part A Cohort 1: The participant must weigh >=40 kilograms (kg) at the time of screening.

Exclusion Criteria:

  1. Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
  2. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
  3. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
  4. Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI).
  5. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.
  6. Participant has a history of chronic or recurrent bacterial disease.
  7. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
  8. Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs/physical examination/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results.
  9. Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.
  10. Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A (Cohort 1): Zasocitinib (Dose A)
Participants (Adolescent) aged 12 to less than (<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.
Drug: Zasocitinib
Zasocitinib.
Other Names:
  • NDI-034858
  • TAK-279
Experimental: Part A (Cohort 2): Zasocitinib (Multiple Doses)
Participants (Children) aged 4 to <12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.
Drug: Zasocitinib
Zasocitinib.
Other Names:
  • NDI-034858
  • TAK-279
Placebo Comparator: Part A (Cohort 1 and Cohort 2): Placebo
Participants in Cohort 1 (Adolescent aged 12 to <18 years) and Cohort 2 (Children aged 4 to <12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.
Drug: Placebo
Zasocitinib matching placebo.
Experimental: Part B: Zasocitinib (Multiple Doses)
Participants (Children) aged 4 to <12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.
Drug: Zasocitinib
Zasocitinib.
Other Names:
  • NDI-034858
  • TAK-279

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater than or Equal to (>=) 2-Point Decrease From Baseline at Week 16
Time Frame: At Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean >= 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5. The percentage of participants achieving an sPGA of Clear (0) or Almost Clear (1) with a >= 2-point decrease from baseline at Week 16 will be reported.
At Week 16
Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
Time Frame: At Week 16
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-75 is defined as 75% improvement from baseline in PASI score. The percentage of participants achieving >= 75% improvement from baseline in PASI score at Week 16 will be reported.
At Week 16
Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib
Time Frame: Pre-dose and Post-dose on Day 7
Cmax of zasocitinib in plasma will be assessed.
Pre-dose and Post-dose on Day 7
Part B: Time to Maximum Concentration (Tmax) of Zasocitinib
Time Frame: Pre-dose and Post-dose on Day 7
Tmax of zasocitinib in plasma will be assessed.
Pre-dose and Post-dose on Day 7
Part B: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-Last) of Zasocitinib
Time Frame: Pre-dose and Post-dose on Day 7
AUC0-Last of zasocitinib in plasma will be assessed.
Pre-dose and Post-dose on Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants Achieving PASI-90 Response at Week 16
Time Frame: At Week 16
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-90 is defined as 90% improvement from baseline in PASI score. The percentage of participants achieving at least 90% or greater reduction in the PASI score from baseline at Week 16 will be assessed.
At Week 16
Part A: Percentage of Participants Achieving an Enhanced sPGA Response of Clear (0) at Week 16
Time Frame: At Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean >= 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5. The percentage of participants achieving an enhanced sPGA response of Clear (0) at Week 16 will be assessed.
At Week 16
Part A: Percentage of Participants Achieving PASI-100 Response at Week 16
Time Frame: At Week 16
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-100 is defined as 100% improvement from baseline in PASI score. The percentage of participants achieving 100% improvement or complete clearance of psoriasis lesions in the PASI score from baseline at Week 16 will be assessed.
At Week 16
Part A: Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) Response of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline for Participants With a Baseline ssPGA >=3 at Week 16
Time Frame: At Week 16
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate more severe scalp psoriasis. The percentage of participants achieving an ssPGA score of at least 3 at baseline who show an ssPGA score of 0 or 1 with a >= 2-point decrease at Week 16 will be reported.
At Week 16
Part A: Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
Time Frame: Baseline, Week 16
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. The change from baseline in BSA affected by psoriasis at Week 16 will be assessed.
Baseline, Week 16
Part A: Percent Change From Baseline in BSA Affected by Psoriasis at Week 16
Time Frame: Baseline, Week 16
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. The percent change from baseline in BSA affected by psoriasis at Week 16 will be assessed.
Baseline, Week 16
Part A: Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score >=2 who Achieve DLQI Score of Zero (0) or One (1) at Week 16
Time Frame: At Week 16
The DLQI is a 10-item validated questionnaire completed by participants aged 16 years or older at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The percentage of participants with a baseline DLQI Score >= 2 who achieve DLQI Score of Zero (0) or One (1) at Week 16 will be assessed.
At Week 16
Part A: Percentage of Participants With a Baseline Children's Dermatology Life Quality Index (CDLQI) Score >=2 who Achieve CDLQI Score of 0 or 1 at Week 16
Time Frame: At Week 16
The CDLQI is a 10-item validated questionnaire completed by participants aged 4 to <16 years of age at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains designed to measure the impact of skin disease on the child's quality of life, including symptoms and feelings, daily activities, leisure, school, personal relationships and treatment. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. The percentage of participants with a baseline CDLQI Score >=2 who achieve CDLQI Score of 0 or 1 at Week 16 will be assessed.
At Week 16
Part A: Change From Baseline in DLQI at Week 16
Time Frame: Baseline, Week 16
The DLQI is a 10-item validated questionnaire completed by participants aged 16 years or older at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The change from baseline in DLQI at Week 16 will be assessed.
Baseline, Week 16
Part A: Change From Baseline in CDLQI at Week 16
Time Frame: Baseline, Week 16
The CDLQI is a 10-item validated questionnaire completed by participants aged 4 to <16 years of age at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains designed to measure the impact of skin disease on the child's quality of life, including symptoms and feelings, daily activities, leisure, school, personal relationships and treatment. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. The change from baseline in CDLQI at Week 16 will be assessed.
Baseline, Week 16
Part A (Cohort 1): Percentage of Participants in Cohort 1 with a Baseline Itch Numerical Rating Scale (NRS) Score >=4 who Achieve a >= 4-Point Improvement in Itch NRS Score at Week 16
Time Frame: At Week 16
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The percentage of participants in Cohort 1 with a baseline Itch NRS Score >=4 who achieve a >=4-Point improvement in Itch NRS Score at Week 16 will be assessed.
At Week 16
Part A (Cohort 1): Change From Baseline in Itch NRS at Week 16
Time Frame: Baseline, Week 16
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The change from baseline in Itch NRS at Week 16 will be assessed.
Baseline, Week 16
Part A (Cohort 1): Percent Change From Baseline in Itch NRS at Week 16
Time Frame: Baseline, Week 16
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The percent change from baseline in Itch NRS at Week 16 will be assessed.
Baseline, Week 16
Parts A and B: Percentage of Participants Achieving PASI-75 Response During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-75 is defined as 75% improvement from baseline in PASI score. The percentage of participants achieving at least 75% or greater reduction in the PASI score from baseline during open-label period will be reported.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants Achieving PASI-90 During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-90 is defined as 90% improvement from baseline in PASI score. The percentage of participants achieving at least 90% or greater reduction in the PASI score from baseline during open-label period will be reported.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants Achieving PASI-100 During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to [<=] 3 representing mild disease, >= 3 to 15 representing moderate disease, and >= 15 indicating severe disease). The PASI-100 is defined as 100% improvement from baseline in PASI score. The percentage of participants achieving 100% improvement or complete clearance of psoriasis lesions in the PASI score from baseline during open-label period will be reported.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean >= 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5. The percentage of participants achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-point decrease from baseline will be reported.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants Achieving an Enhanced sPGA of Clear (0) During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean >= 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5. The percentage of participants achieving an enhanced sPGA of Clear (0) during open-label period will be reported.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants Achieving an ssPGA Response of Clear (0) or Almost Clear (1) with a >=2-point Decrease From Baseline for Participants with a Baseline ssPGA >=3 During Open-Label Period
Time Frame: Part A: Week 16 to Week 208
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate more severe scalp psoriasis. The percentage of participants achieving an ssPGA response of clear (0) or almost clear (1) with a >=2-point decrease from baseline for participants with a baseline ssPGA >=3 during open-label period will be reported.
Part A: Week 16 to Week 208
Parts A and B: Change From Baseline in BSA Affected by Psoriasis During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. The change from baseline in BSA affected by psoriasis during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percent Change From Baseline in BSA Affected by Psoriasis During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. The percent change from baseline in BSA affected by psoriasis during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants With a Baseline DLQI Score >=2 who Achieve DLQI Score of 0 or 1 During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The DLQI is a 10-item validated questionnaire completed by participants aged 16 years or older at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The percentage of participants with a baseline DLQI Score >= 2 who achieve DLQI Score of 0 or 1 during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Percentage of Participants With a Baseline CDLQI Score >=2 who Achieve CDLQI Score of 0 or 1 During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The CDLQI is a 10-item validated questionnaire completed by participants aged 4 to <16 years of age at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains designed to measure the impact of skin disease on the child's quality of life, including symptoms and feelings, daily activities, leisure, school, personal relationships and treatment. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. The percentage of participants with a baseline CDLQI Score >= 2 who achieve CDLQI Score of 0 or 1 during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Change From Baseline in DLQI During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The DLQI is a 10-item validated questionnaire completed by participants aged 16 years or older at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The change from baseline in DLQI during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Parts A and B: Change From Baseline in CDLQI During Open-Label Period
Time Frame: Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
The CDLQI is a 10-item validated questionnaire completed by participants aged 4 to <16 years of age at screening, which is used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The questionnaire covers 6 domains designed to measure the impact of skin disease on the child's quality of life, including symptoms and feelings, daily activities, leisure, school, personal relationships and treatment. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. The change from baseline in CDLQI during open-label period will be assessed.
Part A: Week 16 to Week 208; Part B: Week 1 to Week 208
Part A (Cohort 1): Percentage of Participants with a Baseline Itch Numerical Rating Scale (NRS) Score >=4 who Achieve a >= 4-Point Improvement in Itch NRS Score During Open-Label Period
Time Frame: Part A: Week 16 to Week 208
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The percentage of participants with a baseline Itch NRS score >=4 who achieve a >=4-Point improvement in Itch NRS score during open-label period will be assessed.
Part A: Week 16 to Week 208
Part A (Cohort 1): Change From Baseline in Itch NRS for Participants in Cohort 1 During Open-Label Period
Time Frame: Part A: Baseline, Week 16 to Week 208
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The change from baseline in Itch NRS for participants in Cohort 1 during open-label period will be assessed.
Part A: Baseline, Week 16 to Week 208
Part A (Cohort 1): Percent Change From Baseline in Itch NRS for Participants in Cohort 1 During Open-Label Period
Time Frame: Part A: Baseline, Week 16 to Week 208
The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. The percent change from baseline in Itch NRS for participants in Cohort 1 during open-label period will be assessed.
Part A: Baseline, Week 16 to Week 208
Part A: Plasma Concentrations of Zasocitinib in Participants Receiving Active Treatment
Time Frame: Part A: Week 1 to Week 208
Plasma concentrations of zasocitinib will be assessed using a validated liquid chromatography tandem mass spectrometry bioanalytical method.
Part A: Week 1 to Week 208
Part B: Zasocitinib Acceptability and Palatability Assessment Scores of Participants
Time Frame: Day 1, Day 7 and Day 14
The acceptability and palatability of zasocitinib will be assessed using the Acceptability Palatability Questionnaire. In this 5-item questionnaire, participants will be asked to evaluate the palatability and acceptability of zasocitinib considering the following elements: smell, taste, ease of swallowing, and aftertaste. This questionnaire uses an 11-point scale anchored at 0; a higher score means better acceptability and palatability.
Day 1, Day 7 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2025

Primary Completion (Estimated)

January 24, 2033

Study Completion (Estimated)

January 24, 2033

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TAK-279-PsO-3006
  • 2025-522567-15-00 (Ctis)
  • jRCT2071250114 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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