A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting (ARTISTYK)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 4

Conditions: Psoriasis

Treatments: Drug: Deucravacitinib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05701995

IM011-237

U1111-1276-5158 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
• Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
• ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
• Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
• Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1

Exclusion Criteria:

Target Disease Exceptions:

• Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups, including a placebo group

Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo then Deucravacitinib

Placebo Comparator group

Treatment:

Other: Placebo

Drug: Deucravacitinib