A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 4

Conditions

Palmoplantar Psoriasis

Genital Psoriasis

Treatments

Drug: Placebo

Drug: Deucravacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06042920

2023-504663-16 (EudraCT Number)

IM011-1112

U1111-1289-6934 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.
- A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy.

Inclusion Criteria for Genital Psoriasis

Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.
Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy.

Key Exclusion Criteria:

Target Disease Exceptions

Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.

Other protocol-defined inclusion/exclusion criteria apply.