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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib.
• Препарат Placebo
  Zasocitinib matching placebo.
• Препарат Zasocitinib
  Zasocitinib.

Первичные конечные точки

• 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 [Срок оценки: 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 [Срок оценки: At Week 16]
• Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib [Срок оценки: Pre-dose and Post-dose on Day 7]
• Part B: Time to Maximum Concentration (Tmax) of Zasocitinib [Срок оценки: 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 [Срок оценки: Pre-dose and Post-dose on Day 7]

Вторичные конечные точки (12)

• Part A: Percentage of Participants Achieving PASI-90 Response at Week 16 [Срок оценки: At Week 16]
• Part A: Percentage of Participants Achieving an Enhanced sPGA Response of Clear (0) at Week 16 [Срок оценки: At Week 16]
• Part A: Percentage of Participants Achieving PASI-100 Response at Week 16 [Срок оценки: 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 [Срок оценки: At Week 16]
• Part A: Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 [Срок оценки: Baseline, Week 16]
• Part A: Percent Change From Baseline in BSA Affected by Psoriasis at Week 16 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At Week 16]
• Part A: Change From Baseline in DLQI at Week 16 [Срок оценки: Baseline, Week 16]
• Part A: Change From Baseline in CDLQI at Week 16 [Срок оценки: 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 [Срок оценки: At Week 16]
• Part A (Cohort 1): Change From Baseline in Itch NRS at Week 16 [Срок оценки: Baseline, Week 16]

Критерии участия

Критерии включения

• 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.
• Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (<) 18 years, inclusive.
• Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to <12 years, inclusive.
• Inclusion Criteria for Part A Cohort 1: The participant must weigh >=40 kilograms (kg) at the time of screening.

Критерии исключения

• 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.
• 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.

Other protocol-defined inclusion/exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Exalt Clinical Research — Chula Vista
• First OC Dermatology Research Inc. — Fountain Valley
• Direct Helpers Medical Center — Hialeah
• Arlington Dermatology — Rolling Meadows
• Apex Clinical Research Center, LLC — Canton
• Wright State Physicians — Fairborn
• Apex Clinical Research Center, LLC — Mayfield Heights
• Medical University of South Carolina — Charleston
• … и ещё 3 центра

Китай · 6 центров

• Beijing Children Hospital, Capital Medical University — Пекин
• Dermatology Hospital of Southern Medical University — Гуанчжоу
• Hunan Children's Hospital — Чанша
• Hangzhou First People's Hospital — Ханчжоу
• Peking University Third Hospital — Пекин
• Huashan Hospital Fudan University — Шанхай

Германия · 6 центров

• Johann Wolfgang Goethe-Universität Frankfurt am Main — Frankfurt am Main
• Fachklinik Bad Bentheim — Bad Bentheim
• Uniklinik Koln, Klinik fur Dermatologie und Venerologie — Cologne
• University Hospital of Muenster — Münster
• Universitätsklinikum Bonn — Bonn
• Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz — Mainz

Польша · 6 центров

• Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p — Wroclaw
• Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska — Lublin
• Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie — Rzeszów
• Centrum Badan Klinicznych Pi-house Sp. Z O. O. — Gdansk
• "DERMED" Centrum Medyczne Sp. z o. o. — Lodz
• Dermoklinika-Centrum Medyczne s.c — Lodz

Япония · 5 центров

• Nagoya City University Hospital — Nagoya
• Hospital of the University of Occupational and Environmental Health, Japan — Kitakyushu-shi
• Mie University Hospital — Tsu, Mie
• Nippon Life Hospital — Osaka
• Teikyo University Hospital — Itabashi-Ku

Италия · 3 центра

• Presidio Ospedaliero Gaspare Rodolico — Catania
• Universita Degli Studi Di Padova — Padova
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Испания · 3 центра

• Complejo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela
• Hospital de La Santa Creu i Sant Pau - Dermatologia — Barcelona
• Hospital Universitario 12 de Octubre — Madrid

Идентификаторы

NCT: NCT07250802 · TAK-279-PsO-3006 · 2025-522567-15-00 · jRCT2071250114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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