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

NCT07250802 · Takeda
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Official title
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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 110 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2025-12-04
Estimated completion: 2033-01-24
Last updated: 2026-04-06
Interventions
Drug: ZasocitinibDrug: PlaceboDrug: Zasocitinib
Primary outcomes
  • 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 (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 (At Week 16)
  • Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib (Pre-dose and Post-dose on Day 7)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (40)
Exalt Clinical ResearchRecruiting
Chula Vista, California, United States
First OC Dermatology Research Inc.Recruiting
Fountain Valley, California, United States
Direct Helpers Medical CenterRecruiting
Hialeah, Florida, United States
Arlington DermatologyRecruiting
Rolling Meadows, Illinois, United States
Apex Clinical Research Center, LLCRecruiting
Canton, Ohio, United States
Wright State PhysiciansRecruiting
Fairborn, Ohio, United States
Apex Clinical Research Center, LLCRecruiting
Mayfield Heights, Ohio, United States
Medical University of South CarolinaNot Yet Recruiting
Charleston, South Carolina, United States
UT Physicians Dermatology - Bellaire StationNot Yet Recruiting
Bellaire, Texas, United States
Texas Dermatology and Laser Specialists-San AntonioRecruiting
San Antonio, Texas, United States
Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, United States
Beijing Children Hospital, Capital Medical UniversityNot Yet Recruiting
Beijing, Beijing Municipality, China
Dermatology Hospital of Southern Medical UniversityNot Yet Recruiting
Guangzhou, Guangdong, China
Hunan Children's HospitalNot Yet Recruiting
Changsha, Hunan, China
Hangzhou First People's HospitalNot Yet Recruiting
Hangzhou, Zhejiang, China
Peking University Third HospitalNot Yet Recruiting
Beijing, China
Huashan Hospital Fudan UniversityRecruiting
Shanghai, China
Johann Wolfgang Goethe-Universität Frankfurt am MainNot Yet Recruiting
Frankfurt am Main, Hesse, Germany
Fachklinik Bad BentheimNot Yet Recruiting
Bad Bentheim, Lower Saxony, Germany
Uniklinik Koln, Klinik fur Dermatologie und VenerologieNot Yet Recruiting
Cologne, North Rhine-Westphalia, Germany
University Hospital of MuensterNot Yet Recruiting
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum BonnNot Yet Recruiting
Bonn, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet MainzNot Yet Recruiting
Mainz, Germany
Presidio Ospedaliero Gaspare RodolicoNot Yet Recruiting
Catania, Sicily, Italy
Universita Degli Studi Di PadovaNot Yet Recruiting
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSNot Yet Recruiting
Rome, Italy
Nagoya City University HospitalRecruiting
Nagoya, Aichi-ken, Japan
Hospital of the University of Occupational and Environmental Health, JapanRecruiting
Kitakyushu-shi, Fukuoka, Japan
Mie University HospitalRecruiting
Tsu, Mie, Mie-ken, Japan
Nippon Life HospitalRecruiting
Osaka, Osaka, Japan
Teikyo University HospitalNot Yet Recruiting
Itabashi-Ku, Tokyo, Japan
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.pNot Yet Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota KrasowskaNot Yet Recruiting
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w RzeszowieNot Yet Recruiting
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Badan Klinicznych Pi-house Sp. Z O. O.Not Yet Recruiting
Gdansk, Pomeranian Voivodeship, Poland
"DERMED" Centrum Medyczne Sp. z o. o.Not Yet Recruiting
Lodz, Poland
Dermoklinika-Centrum Medyczne s.cNot Yet Recruiting
Lodz, Poland
Complejo Hospitalario Universitario de Santiago de CompostelaNot Yet Recruiting
Santiago de Compostela, A Coruna, Spain
Hospital de La Santa Creu i Sant Pau - DermatologiaNot Yet Recruiting
Barcelona, Spain
Hospital Universitario 12 de OctubreNot Yet Recruiting
Madrid, Spain
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis · TrialPath