A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular… (NCT06042920) | Clinical Trial Compass
TerminatedPhase 4
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Stopped: Business objectives have changed
United States130 participantsStarted 2023-10-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-…
What they're measuring
1
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
Timeframe: Week 16
2
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response