Long-Term Study of Zasocitinib for Plaque Psoriasis in Children and Teenagers
This study is looking at how well and how safely a medicine called zasocitinib works for children and teenagers (ages 4 to 17) who have moderate-to-severe plaque psoriasis. Plaque psoriasis is a long-lasting skin condition that causes patches of thick, red skin covered with silvery scales. The study will have two parts. In Part A, participants will either receive zasocitinib or a placebo (an inactive substance) for the first 16 weeks. After that, everyone in Part A will receive zasocitinib. Initially, only teenagers can join, and children may join later. The main goals are to see how many participants achieve clear or almost clear skin, and how much their psoriasis improves after 16 weeks.
- Study design
- This is an interventional study with a planned enrollment of 110 participants. In Part A, participants will be assigned to receive either zasocitinib or a placebo, then all will receive zasocitinib.
- What's involved
- Participants will receive zasocitinib or placebo for at least 16 weeks. Blood samples will be taken to measure zasocitinib levels on Day 7.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main study goals are measured at Week 16, and zasocitinib levels are measured on Day 7. All participants in Part A will receive zasocitinib through the end of the study, but the total study duration is not specified.
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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
At a glance
Conditions
Where it's being run
40 sites across 30 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- 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 16At 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.
- Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16At 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.
- Part B: Maximum Observed Plasma Concentration (Cmax) of ZasocitinibPre-dose and Post-dose on Day 7
Cmax of zasocitinib in plasma will be assessed.
- Part B: Time to Maximum Concentration (Tmax) of ZasocitinibPre-dose and Post-dose on Day 7
Tmax of zasocitinib in plasma will be assessed.
- Part B: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-Last) of ZasocitinibPre-dose and Post-dose on Day 7
AUC0-Last of zasocitinib in plasma will be assessed.