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NCT Number: NCT06258668

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

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.

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Key information

Conditions

Moderate-to-severe Plaque Psoriasis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Seoul, South Korea

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Deucravacitinib

Drug

As per product label

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 24 weeks from treatment initiation

  2. Number of participants with adverse drug reactions (ADRs)

    Time frame: Up to 24 weeks from treatment initiation

  3. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 24 weeks from treatment initiation

  4. Number of participants with serious adverse drug reactions (SADRs)

    Time frame: Up to 24 weeks from treatment initiation

  5. Number of participants with unexpected adverse events (AEs)

    Time frame: Up to 24 weeks from treatment initiation

  6. Number of participants with unexpected adverse drug reactions (ADRs)

    Time frame: Up to 24 weeks from treatment initiation

  7. Number of participants with unexpected serious adverse events (SAEs)

    Time frame: Up to 24 weeks from treatment initiation

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

    Time frame: Up to 24 weeks from treatment initiation

Secondary outcomes

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

    Time frame: At Week 16 and/or Week 24 post treatment initiation

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

    Time frame: At Week 16 and/or Week 24 post treatment initiation

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 14, 2024
Registry last updated
Nov 6, 2024

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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