This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.
Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Roflumilast cream 0.3% for topical application
Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs \[TEAEs\]) in ARQ-151-202 are presented.
Time frame: Up to 52 weeks
Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time frame: Up to 52 weeks
Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.
Time frame: Weeks 12, 24, 36, and 52
Duration of Response in Participants Achieving 'Clear' IGA Score
The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.
Time frame: Up to 52 weeks
Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear'
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Arcutis Clinical Site 35
Beverly Hills, California, United States
Arcutis Clinical Site 29
Northridge, California, United States
Arcutis Clinical Site 28
San Diego, California, United States
Arcutis Clinical Site 27
Santa Monica, California, United States
Arcutis Clinical Site 12
Miami, Florida, United States
Arcutis Clinical Site 16
Sanford, Florida, United States
Arcutis Clinical Site 21
Louisville, Kentucky, United States
Arcutis Clinical Site 34
Clinton Township, Michigan, United States
Arcutis Clinical Site 33
Detroit, Michigan, United States
Arcutis Clinical Site 20
Fridley, Minnesota, United States
...and 20 more locations
The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.
Time frame: Weeks 12, 24, 36, and 52
Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)
The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
Time frame: Baseline and Weeks 12, 24, 36, and 52