Clinical trial NCT06042920: A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Palmoplantar Psoriasis
Genital Psoriasis
Keywords: Deucravacitinib
BMS-986165
SOTYKTU
Plaque psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score
timeFrame: Baseline to Week 16
measure: Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction
timeFrame: Baseline to Week 16
measure: Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction
timeFrame: Baseline to Week 16
measure: Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score
timeFrame: Baseline to Week 16
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Week 16
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Week 16
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to Week 16
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0050
state: Arizona
city: Fountain Valley
country: United States
facility: Local Institution - 0015
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0009
state: California
city: Santa Monica
country: United States
facility: Local Institution - 0004
state: California
city: Skokie
country: United States
facility: Local Institution - 0057
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0052
state: Indiana
city: Plainfield
country: United States
facility: Local Institution - 0053
state: Indiana
city: Rockville
country: United States
facility: Local Institution - 0029
state: Maryland
city: Detroit
country: United States
facility: Local Institution - 0012
state: Michigan
city: East Windsor
country: United States
facility: Local Institution - 0005
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0002
state: New York
city: New York
country: United States
facility: Local Institution - 0008
state: New York
city: New York
country: United States
facility: Local Institution - 0062
state: New York
city: Winston-Salem
country: United States
facility: Local Institution - 0001
state: North Carolina
city: Boardman
country: United States
facility: Local Institution - 0066
state: Ohio
city: Mayfield Heights
country: United States
facility: Local Institution - 0055
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0056
state: Pennsylvania
city: Houston
country: United States
facility: Local Institution - 0010
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0007
state: Virginia
city: Mill Creek
country: United States
facility: Local Institution - 0033
state: Washington
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Local Institution - 0043
state: B
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Local Institution - 0037
state: B
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Local Institution - 0034
state: C
city: Rosario
country: Argentina
facility: Local Institution - 0042
state: S
city: Newmarket
country: Canada
facility: Local Institution - 0058
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0060
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0065
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0054
state: Quebec
city: Québec
country: Canada
facility: Local Institution - 0059
state: Quebec
city: Saint-Jerome
country: Canada
facility: Local Institution - 0061
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution - 0064
state: Saskatchewan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: