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

Purpose

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

Conditions

  • Palmoplantar Psoriasis
  • Genital Psoriasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Deucravacitinib
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
    • SOTYKTU
  • Drug: Placebo
    Specified dose on specified days
Placebo Comparator
Placebo followed by Deucravacitinib
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
    • SOTYKTU
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Dermatology Research Associates - Howard Sofen, MD
Los Angeles, California 90045-3606
Contact:
Howard Sofen, Site 0009

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

First Name: BMS Study Connect Contact Center Last Name: www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com