Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07250802 | A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis | PHASE3 | RECRUITING | 110 | — | — | Dec 4, 2025 | Jan 24, 2033 | May 8, 2026 | 40 | United States, China +5 |
| NCT06973291 | A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis | PHASE3 | COMPLETED | 606 | — | — | Jul 9, 2025 | Apr 22, 2026 | May 1, 2026 | 113 | United States, Bulgaria +6 |
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.
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.
Cmax of zasocitinib in plasma will be assessed.
Tmax of zasocitinib in plasma will be assessed.
AUC0-Last of zasocitinib in plasma will be assessed.
PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling 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 produces a numeric score that can range from 0 to 72 (less than or equal to \[\<=\] 3 representing mild disease, greater than or equal to \[\>=3\] to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100 percentage (%) improvement in PASI score relative to baseline PASI score will be reported.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Zasocitinib or Placebo | EXPERIMENTAL | Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16. |
| Deucravacitinib or Placebo | ACTIVE_COMPARATOR | Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16. |
| Name | Type | Description |
|---|---|---|
| Zasocitinib | DRUG | Zasocitinib. |
| Placebo | DRUG | Zasocitinib matching placebo. |
| Deucravacitinib | DRUG | Deucravacitinib capsules. |
| Placebo to match zasocitinib | DRUG | Zasocitinib matching placebo tablets. |
| Placebo to match deucravacitinib | DRUG | Deucravacitinib matching placebo capsules. |
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 ...