A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China (ADMIRE)
A Prospective Observational Study to Evaluate the Effectiveness of Deucravacitinib in Patients With Moderate Plaque Psoriasis in Real-World Settings in China (ADMIRE)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Contact Backup
- Name: First line of the email MUST contain NCT # and Site #.
Study Locations
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-
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Beijing, China, 102218
- Local Institution - 0003
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Guangdong
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Guangzhou, Guangdong, China, 510091
- Local Institution - 0001
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Hebei
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Handan, Hebei, China, 056029
- Local Institution - 0002
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Liaoning
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Dalian, Liaoning, China, 116021
- Local Institution - 0005
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200080
- Local Institution - 0004
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Participants treated with deucravacitinib
Adults with moderate plaque psoriasis who are newly initiating deucravacitinib according to the product label
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As per product label
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score
Time Frame: Week 16
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Week 16
|
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Participant psoriasis Body Surface Area (BSA) involvement
Time Frame: Week 16
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Week 16
|
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Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3
Time Frame: Week 16
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Week 16
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response
Time Frame: Baseline and Weeks 4, 12, 24, 36, and 52
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Baseline and Weeks 4, 12, 24, 36, and 52
|
|
Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤1, ≤2, ≤3, and ≤5
Time Frame: Baseline and Weeks 4, 12, 24, 36, and 52
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Baseline and Weeks 4, 12, 24, 36, and 52
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|
Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline
Time Frame: Weeks 4, 12, 16, 24, 36, and 52
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Weeks 4, 12, 16, 24, 36, and 52
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Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%
Time Frame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Change in Body Surface Area (BSA) involvement from baseline to follow-up
Time Frame: Weeks 4, 12, 24, 36, and 52
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Weeks 4, 12, 24, 36, and 52
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Static Physician's Global Assessment (sPGA) 0/1 response at follow-up
Time Frame: Weeks 4, 12, 24, 36, and 52
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Weeks 4, 12, 24, 36, and 52
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|
Participants change in Static Physician's Global Assessment (sPGA) score from baseline
Time Frame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Baseline and Weeks 4, 12, 16, 24, 36, and 52
|
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Number of participants achieving a Dermatology Life Quality Index (DLQI) 0/1 score
Time Frame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Number of participants achieving a Dermatology Life Quality Index (DLQI) ≤ 3 score
Time Frame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Baseline and Weeks 4, 12, 16, 24, 36, and 52
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|
Change in participant Dermatology Life Quality Index (DLQI) score from baseline
Time Frame: Baseline and Weeks 4, 12, 16, 24, 36, and 52
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Baseline and Weeks 4, 12, 16, 24, 36, and 52
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IM011-1180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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