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

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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

Study Start (Actual) 2023-10-09

Primary Completion (Estimated) 2026-01-21

Study Completion (Estimated) 2026-10-28

Enrollment (Estimated) 360

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Birmingham, Alabama, United States

📍 Phoenix, Arizona, United States

📍 Fountain Valley, California, United States

📍 Los Angeles, California, United States

📍 Santa Monica, California, United States

📍 Rolling Meadows, Illinois, United States

📍 Skokie, Illinois, United States

📍 Indianapolis, Indiana, United States

📍 Plainfield, Indiana, United States

📍 Rockville, Maryland, United States

📍 Detroit, Michigan, United States

📍 East Windsor, New Jersey, United States

📍 New York, New York, United States

📍 Winston-Salem, North Carolina, United States

📍 Boardman, Ohio, United States

📍 Mayfield Heights, Ohio, United States

📍 Portland, Oregon, United States

📍 Pittsburgh, Pennsylvania, United States

📍 Charleston, South Carolina, United States

📍 Houston, Texas, United States

📍 Norfolk, Virginia, United States

📍 Mill Creek, Washington, United States

📍 Ciudad Autónoma Buenos Aires, B, Argentina

📍 Ciudad Autonoma Buenos Aires, C, Argentina

📍 Rosario, S, Argentina

📍 Newmarket, Ontario, Canada

📍 Niagara Falls, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Montreal, Quebec, Canada

📍 Québec, Quebec, Canada

📍 Saint-Jerome, Quebec, Canada

📍 Saskatoon, Saskatchewan, Canada

📍 Berlin, BE, Germany

📍 Memmingen, BY, Germany

📍 Frankfurt am Main, Hesse, Germany

📍 Hamburg, HH, Germany

📍 Witten, Northwest, Germany

📍 Mainz, RP, Germany

📍 Brescia, BS, Italy

📍 Roma, RM, Italy

📍 Wroclaw, DS, Poland

📍 Warsaw, Mazowieckie, Poland

📍 Warszawa, Mazowieckie, Poland

📍 Bialystok, PD, Poland

📍 Rzeszow, PK, Poland

📍 Madrid, M, Spain

📍 Córdoba, X, Spain

📍 Barcelona, Spain

More locations available...

Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-09-12
First Submitted that Met QC Criteria2023-09-12
First Posted2023-09-21

Study Record Updates

Last Update Submitted that Met QC Criteria2024-06-25
Last Update Posted2024-06-27
Last Verified2024-06