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

February 3, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants diagnosed with moderate-to-severe plaque psoriasis
Drug: Deucravacitinib
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with adverse drug reactions (ADRs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with serious adverse drug reactions (SADRs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse events (AEs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse drug reactions (ADRs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse events (SAEs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse drug reactions (SADRs)
Time Frame: Up to 24 weeks from treatment initiation
Up to 24 weeks from treatment initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: At Week 16 and/or Week 24 post treatment initiation
At Week 16 and/or Week 24 post treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-1122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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