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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06042920
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Canada, Germany, Italy, Poland, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Palmoplantar Psoriasis, Genital Psoriasis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Deucravacitinib

Placebo Comparator: Placebo followed by Deucravacitinib

Interventions

Drug: - Deucravacitinib

Specified dose on specified days

Drug: - Placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Whitaker Clinic of UAB Hospital, Birmingham, Alabama

Status

Not yet recruiting

Address

Whitaker Clinic of UAB Hospital

Birmingham, Alabama, 35233-3110

Site Contact

Bonnie Elewski, Site 0022

Clinical Trial Finder