The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Specified dose on specified days.
Specified dose on specified days.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.
Time frame: At Week 16
Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all 1. = A little 2. = A lot 3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.
Time frame: At Week 16
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16
The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching.
Time frame: Baseline and at Week 16
Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
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Local Institution - 0006
Phoenix, Arizona, United States
Local Institution - 0034
Scottsdale, Arizona, United States
Local Institution - 0015
North Little Rock, Arkansas, United States
Local Institution - 0004
Bakersfield, California, United States
Local Institution - 0009
Sacramento, California, United States
Local Institution - 0022
San Diego, California, United States
Local Institution - 0030
Centennial, Colorado, United States
Local Institution - 0024
Washington D.C., District of Columbia, United States
Local Institution - 0027
Brandon, Florida, United States
Local Institution - 0016
Coral Gables, Florida, United States
...and 28 more locations
The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis.
Time frame: At Week 16
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Time frame: From Week 0 through Week 16
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From Week 0 through Week 16
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal
Time frame: From Week 0 through Week 16
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16
Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.
Time frame: From Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Time frame: From Week 0 through Week 16
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16
Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.
Time frame: From Week 0 through Week 16