Clinical trial NCT06512337: A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China
Official title: A Prospective Observational Study to Evaluate the Effectiveness of Deucravacitinib in Patients With Moderate Plaque Psoriasis in Real-World Settings in China (ADMIRE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plaque Psoriasis
Keywords: Plaque psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants aged ≥ 18 years who have been diagnosed with moderate plaque psoriasis who are starting deucravacitinib treatment in China

Brief summary: The purpose of this study is to collect and evaluate real-world data on the effectiveness of deucravacitinib treatment in adults with moderate plaque psoriasis in China.


Eligibility criteria: Inclusion Criteria:

* Participant aged 18 years or older
* Physician-reported (dermatologist) diagnosis of moderate plaque psoriasis with Body Surface Area ≥ 3% and \< 10%
* Participant newly initiated deucravacitinib according to the label
* Provided written informed consent to participate in the study

Exclusion Criteria:

* Participating in or planning to participate in an interventional clinical trial
* Concomitant use of other systemic treatments for psoriasis at baseline
* Prior treatment of deucravacitinib

Primary outcomes:
measure: Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score
timeFrame: Week 16
measure: Participant psoriasis Body Surface Area (BSA) involvement
timeFrame: Week 16
measure: Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3
timeFrame: Week 16
Secondary outcomes:
measure: Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response
timeFrame: Baseline and Weeks 4, 12, 24, 36, and 52
measure: Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤1, ≤2, ≤3, and ≤5
timeFrame: Baseline and Weeks 4, 12, 24, 36, and 52
measure: Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline
timeFrame: Weeks 4, 12, 16, 24, 36, and 52
measure: Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%
timeFrame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
measure: Change in Body Surface Area (BSA) involvement from baseline to follow-up
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Static Physician's Global Assessment (sPGA) 0/1 response at follow-up
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Participants change in Static Physician's Global Assessment (sPGA) score from baseline
timeFrame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) 0/1 score
timeFrame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) ≤ 3 score
timeFrame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
measure: Change in participant Dermatology Life Quality Index (DLQI) score from baseline
timeFrame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: