Deucravacitinib
DrugSpecified dose on specified days.
Other names: BMS-986165, Sotyktu
NCT Number: NCT05701995
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Local Institution - 0040, Caguas, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Target Disease Exceptions:
Other protocol-defined inclusion/exclusion criteria apply.
Specified dose on specified days.
Other names: BMS-986165, Sotyktu
Specified dose on specified days.
Time frame: 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
Time frame: 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
Time frame: Baseline and 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: At Week 16
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: From Week 0 through 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
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.
ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal
Time frame: From Week 0 through 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 including heart rate, systolic blood pressure, and diastolic blood pressure.
Time frame: From Week 0 through 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.
Bristol-Myers Squibb
Industry
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
Acronym: ARTISTYK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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