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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Deucravacitinib

    Drug

    As per product label

Treatment groups

505 Participants
are divided into 1 treatment group
Group A: Participants diagnosed with moderate-to-severe plaque psoriasis1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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