The main aim of this study is to assess whether zasocitinib works better than deucravacitinib in treating participants with moderate-to-severe plaque psoriasis. Participants will take one tablet daily of either zasocitinib or a matching placebo, along with one capsule daily of either over-encapsulated deucravacitinib or a matching placebo, for a duration of 16 weeks. Participants will be in the study for up to 25 weeks, which includes screening period of up to 35 days, a 16-week treatment period, and a 4-week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
606
Zasocitinib tablets.
Deucravacitinib capsules.
Zasocitinib matching placebo tablets.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16
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.
Time frame: At Week 16
Percentage of Participants Achieving PASI-90 at Weeks 4, 8, 12, and 16
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 (\<= 3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: At Weeks 4, 8, 12, and 16
Percentage of Participants Achieving PASI <=2 Response at Weeks 4, 8, 12, and 16
PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling (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 (\<= 3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants achieving PASI \<=2 at Weeks 4, 8, 12, and 16 will be reported.
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Deucravacitinib matching placebo capsules.
Johnson Dermatology
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Zenith Research, Inc.
Beverly Hills, California, United States
First OC Dermatology Research Inc.
Fountain Valley, California, United States
UNISON Clinical Trials (Shahram Jacobs md inc.)
Sherman Oaks, California, United States
Central Connecticut Dermatology, PLLC
Cromwell, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Direct Helpers Research Center
Hialeah, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
...and 103 more locations
Time frame: At Weeks 4, 8, 12, and 16
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear (0) at Weeks 4, 8, 12, and 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.
Time frame: At Weeks 4, 8, 12, and 16
Percentage of Participants Achieving PASI-100 at Weeks 4, 8, and 12
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 (\<= 3 representing mild disease, \>=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% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: At Weeks 4, 8, and 12
Percentage of Participants Achieving PASI-75 at Weeks 4, 8, 12, and 16
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, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: At Weeks 4, 8, 12, and 16
Percentage of Participants Achieving sPGA of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, and 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: At Weeks 4, 8, 12, and 16
Change From Baseline in PASI Score at Weeks 4, 8, 12, and 16
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 (\<= 3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Change from baseline will be calculated as post-baseline value minus baseline value.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Percent Change From Baseline in PASI score at Weeks 4, 8, 12, and 16
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 (\<= 3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percent change from baseline will be calculated as post-baseline value minus baseline value multiplied by 100.
Time frame: Baseline, Weeks 4, 8, 12, and 16