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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Plaque Psoriasis
Date of first enrollment	04/12/2025
Target sample size	110
Countries of recruitment	China,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Spain,Japan,United States,Japan
Study type	Interventional
Intervention(s)	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 oral tablet from Week 16 to Week 208 during the open-label period. 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. 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. 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.

Outcome(s)

Primary Outcome

1.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. 2.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. 3.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. 4.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. 5.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.

Secondary Outcome

1.Part A: Percentage of Participants Achieving PASI-90 Response at Week 16 Time Frame: At Week 16 The PASI-90 is defined as 90% improvement from baseline in PASI score. 2.Part A: Percentage of Participants Achieving an Enhanced sPGA Response of Clear (0) at Week 16 Time Frame: At Week 16 3.Part A: Percentage of Participants Achieving PASI-100 Response at Week 16 Time Frame: At Week 16 The PASI-100 is defined as 100% improvement from baseline in PASI score. 4.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. 5.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. 6.Part A: Percent Change From Baseline in BSA Affected by Psoriasis at Week 16 Time Frame: Baseline, Week 16 7.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). 8.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. 9.Part A: Change From Baseline in DLQI at Week 16 Time Frame: Baseline, Week 16 10.Part A: Change From Baseline in CDLQI at Week 16 Time Frame: At Week 16 11.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'. 12.Part A (Cohort 1): Change From Baseline in Itch NRS at Week 16 Time Frame: Baseline, Week 16 13.Part A (Cohort 1): Percent Change From Baseline in Itch NRS at Week 16 Time Frame: Baseline, Week 16 14.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-75 is defined as 75% improvement from baseline in PASI score. 15.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 16.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 17.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 18.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 19.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; Part B: Week 1 to Week 208 20.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 21.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 22.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 23.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 24.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 25.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 26.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 27.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 28.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 29.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. 30.Part B: Zasocitinib Acceptibility or Palatability Assessment Scores of Participants Time Frame: Day 1, Day 7 and Day 14 The zasocitinib acceptability or palatability of chewing tablet will be assessed using the 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 palatability.

Key inclusion & exclusion criteria

Age minimum	>= 4age old
Age maximum	<= 17age old
Gender	Both
Include 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 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.
Exclude 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.