Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

NCT06258668 | Recruiting FDA Drug

• 1 other identifier: IM011-1122
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.

Conditions

Moderate-to-severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (8)

• Number of participants with adverse events (AEs)

  Up to 24 weeks from treatment initiation

• Number of participants with adverse drug reactions (ADRs)

  Up to 24 weeks from treatment initiation

• Number of participants with serious adverse events (SAEs)

  Up to 24 weeks from treatment initiation

• Number of participants with serious adverse drug reactions (SADRs)

  Up to 24 weeks from treatment initiation

• Number of participants with unexpected adverse events (AEs)

  Up to 24 weeks from treatment initiation

• Number of participants with unexpected adverse drug reactions (ADRs)

  Up to 24 weeks from treatment initiation

• Number of participants with unexpected serious adverse events (SAEs)

  Up to 24 weeks from treatment initiation

• Number of participants with unexpected serious adverse drug reactions (SADRs)

  Up to 24 weeks from treatment initiation

Secondary Outcomes (2)

• Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1

  At Week 16 and/or Week 24 post treatment initiation

• Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)

  At Week 16 and/or Week 24 post treatment initiation

Study Arms (1)

Participants diagnosed with moderate-to-severe plaque psoriasis

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

As per product label

Participants diagnosed with moderate-to-severe plaque psoriasis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients in Korea who have been diagnosed with moderate-to-severe plaque psoriasis and have been prescribed treatment with deucravacitinib according to the approved product label.

You may qualify if:

• Adult participants ≥19 years of age
• Diagnosis of moderate-to-severe plaque psoriasis
• Candidate for phototherapy or systemic therapy
• Will begin deucravacitinib according to approved product label

You may not qualify if:

• Participants prescribed deucravacitinib for therapeutic indications not approved in Korea
• Participants for whom deucravacitinib is contraindicated as clarified in Korean prescribing information by ministry of food and drug safety (MFDS)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Seoul, 06234, South Korea

WITHDRAWN

Novotech Laboratory Korea Co., Ltd.

Seoul, 06234, South Korea

RECRUITING

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

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

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

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 14, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)