A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

NCT06512337 | Active Not Recruiting FDA Drug

• 1 other identifier: IM011-1180
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 5

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.

Conditions

Plaque Psoriasis

Keywords

Plaque psoriasis

Outcome Measures

Primary Outcomes (3)

• Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score

  Week 16

• Participant psoriasis Body Surface Area (BSA) involvement

  Week 16

• Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3

  Week 16

Secondary Outcomes (10)

• Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response

  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

  Baseline and Weeks 4, 12, 24, 36, and 52

• Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline

  Weeks 4, 12, 16, 24, 36, and 52

• Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%

  Baseline and Weeks 4, 12, 16, 24, 36, and 52

• Change in Body Surface Area (BSA) involvement from baseline to follow-up

  Weeks 4, 12, 24, 36, and 52

Study Arms (1)

Participants treated with deucravacitinib

Adults with moderate plaque psoriasis who are newly initiating deucravacitinib according to the product label

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

As per product label

Participants treated with deucravacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Local Institution - 0001

Guangzhou, Guangdong, 510091, China

Location

Local Institution - 0002

Handan, Hebei, 056029, China

Location

Local Institution - 0005

Dalian, Liaoning, 116021, China

Location

Local Institution - 0004

Shanghai, Shanghai Municipality, 200080, China

Location

Local Institution - 0003

Beijing, 102218, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)