This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
304
experimental
experimental
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Time frame: Week 8
Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Time frame: Week 8
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only.
Time frame: Baseline and Weeks 2, 4, 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity.
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Arcutis Biotherapeutics Clinical Site 71
Rogers, Arkansas, United States
Arcutis Biotherapeutics Clinical Site 72
Fremont, California, United States
Arcutis Biotherapeutics Clinical Site 85
San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 21
Cromwell, Connecticut, United States
Arcutis Biotherapeutics Clinical Site 91
Boynton Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 20
Coral Gables, Florida, United States
Arcutis Biotherapeutics Clinical Site 88
Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 90
Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 83
Sweetwater, Florida, United States
Arcutis Biotherapeutics Clinical Site 99
Rolling Meadows, Illinois, United States
...and 37 more locations
Time frame: Baseline and Weeks 4 and 8
Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only.
Time frame: Up to 8 weeks
Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Time frame: Week 8
Number of Participants Achieving PSSI-90
The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Time frame: Baseline and Week 8