A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-17
SponsorTakeda
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Zasocitinib
DrugZasocitinib.
Placebo
DrugZasocitinib matching placebo.
Zasocitinib
DrugZasocitinib.
Treatment groups
110 Participants
are divided into 4 treatment groupsGroup A: Part A (Cohort 1): Zasocitinib (Dose A)Experimental treatment 1 intervention
Group B: Part A (Cohort 2): Zasocitinib (Multiple Doses)Experimental treatment 1 intervention
Group C: Part A (Cohort 1 and Cohort 2): PlaceboPlacebo comparator 1 intervention
Group D: Part B: Zasocitinib (Multiple Doses)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
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.
Time frame
At Week 162
Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score 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.
Time frame
At Week 163
Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib
Cmax of zasocitinib in plasma will be assessed.
Time frame
Pre-dose and Post-dose on Day 74
Part B: Time to Maximum Concentration (Tmax) of Zasocitinib
Tmax of zasocitinib in plasma will be assessed.
Time frame
Pre-dose and Post-dose on Day 7Secondary outcomes
1
Part A: Percentage of Participants Achieving PASI-90 Response 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-90 is defined as 90% improvement from baseline in PASI score. The percentage of participants achieving at least 90% or greater reduction in the PASI score from baseline at Week 16 will be assessed.
Time frame
At Week 162
Part A: Percentage of Participants Achieving an Enhanced sPGA Response of Clear (0) 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 enhanced sPGA response of Clear (0) at Week 16 will be assessed.
Time frame
At Week 163
Part A: Percentage of Participants Achieving PASI-100 Response 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-100 is defined as 100% improvement from baseline in PASI score. The percentage of participants achieving 100% improvement or complete clearance of psoriasis lesions in the PASI score from baseline at Week 16 will be assessed.
Time frame
At Week 164
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
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. The percentage of participants achieving an ssPGA score of at least 3 at baseline who show an ssPGA score of 0 or 1 with a \>= 2-point decrease at Week 16 will be reported.
Time frame
At Week 16 Source ClinicalTrials.gov