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

NCT07250802 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: TAK-279-PsO-30062025-522567-15-00jRCT2071250114
• Study Type: interventional
• Target: 110
• Locations: 7 countries
• Sites: 40

Brief Summary

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.

Conditions

Plaque Psoriasis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  AUC0-Last of zasocitinib in plasma will be assessed.

  Pre-dose and Post-dose on Day 7

Secondary Outcomes (30)

• Part A: Percentage of Participants Achieving PASI-90 Response at Week 16

  At Week 16

• Part A: Percentage of Participants Achieving an Enhanced sPGA Response of Clear (0) at Week 16

  At Week 16

• Part A: Percentage of Participants Achieving PASI-100 Response at Week 16

  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

  At Week 16

• Part A: Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

  Baseline, Week 16

Study Arms (4)

Part A (Cohort 1): Zasocitinib (Dose A)

EXPERIMENTAL

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

Part A (Cohort 2): Zasocitinib (Multiple Doses)

EXPERIMENTAL

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

Part A (Cohort 1 and Cohort 2): Placebo

PLACEBO COMPARATOR

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

Part B: Zasocitinib (Multiple Doses)

EXPERIMENTAL

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

Interventions

Zasocitinib DRUG

Zasocitinib.

Also known as: TAK-279, NDI-034858

Part A (Cohort 1): Zasocitinib (Dose A)

Placebo DRUG

Zasocitinib matching placebo.

Part A (Cohort 1 and Cohort 2): Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\>=) 6 months prior to the screening visit.
• 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.
• 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.
• Participant has plaque psoriasis covering \>=10 percent (%) of total body surface area (BSA) at screening and Day 1.
• Participant must be a candidate for phototherapy or systemic therapy.

You may not qualify if:

• Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
• Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
• 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).
• Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.
• Participant has a history of chronic or recurrent bacterial disease.
• Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
• 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.
• 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.
• Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.

Sponsors & Collaborators

• Takeda: lead

Study Sites (40)

Exalt Clinical Research

Chula Vista, California, 91910, United States

RECRUITING

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States

RECRUITING

Direct Helpers Medical Center

Hialeah, Florida, 33012, United States

RECRUITING

Arlington Dermatology

Rolling Meadows, Illinois, 60008-3811, United States

RECRUITING

Apex Clinical Research Center, LLC

Canton, Ohio, 44718, United States

RECRUITING

Wright State Physicians

Fairborn, Ohio, 45324, United States

RECRUITING

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, 44124-4005, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

UT Physicians Dermatology - Bellaire Station

Bellaire, Texas, 77401, United States

NOT YET RECRUITING

Texas Dermatology and Laser Specialists-San Antonio

San Antonio, Texas, 78218-3128, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Beijing Children Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

NOT YET RECRUITING

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

NOT YET RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

NOT YET RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, 100191, China

NOT YET RECRUITING

Huashan Hospital Fudan University

Shanghai, 200040, China

NOT YET RECRUITING

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, 60596, Germany

NOT YET RECRUITING

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

NOT YET RECRUITING

Uniklinik Koln, Klinik fur Dermatologie und Venerologie

Cologne, North Rhine-Westphalia, 50937, Germany

NOT YET RECRUITING

University Hospital of Muenster

Münster, North Rhine-Westphalia, 48145, Germany

NOT YET RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

NOT YET RECRUITING

Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

Mainz, 55131, Germany

NOT YET RECRUITING

Presidio Ospedaliero Gaspare Rodolico

Catania, Sicily, 95123, Italy

NOT YET RECRUITING

Universita Degli Studi Di Padova

Padua, 35121, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

NOT YET RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

NOT YET RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, Fukuoka, 807-8555, Japan

RECRUITING

Mie University Hospital

Tsu, Mie, Mie-ken, 514-8507, Japan

RECRUITING

Nippon Life Hospital

Osaka, Osaka, 550-0006, Japan

RECRUITING

Teikyo University Hospital

Itabashi-Ku, Tokyo, 173-0003, Japan

NOT YET RECRUITING

Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

NOT YET RECRUITING

Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

Lublin, Lublin Voivodeship, 20-573, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

NOT YET RECRUITING

Centrum Badan Klinicznych Pi-house Sp. Z O. O.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

NOT YET RECRUITING

"DERMED" Centrum Medyczne Sp. z o. o.

Lodz, 90-265, Poland

NOT YET RECRUITING

Dermoklinika-Centrum Medyczne s.c

Lodz, 90-436, Poland

NOT YET RECRUITING

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

NOT YET RECRUITING

Hospital de La Santa Creu i Sant Pau - Dermatologia

Barcelona, 08041, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A: Double-blinded and Open-label; Part B: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): January 24, 2033
• Study Completion (Estimated): January 24, 2033
• Last Updated: March 9, 2026

Record last verified: 2026-03

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

IT (3); DE (6); US (11); CN (6); JP (5); PL (6); ES (3)