Trial Outcomes & Findings for Deucravacitinib for the Treatment of Palmoplantar Pustulosis (NCT NCT05710185)

Results Overview

The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

16 weeks

Results posted on

2025-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects with Palmoplantar pustulosis All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects with Palmoplantar pustulosis All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Palmoplantar Pustulosis n=3 Participants All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Age, Categorical >=65 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=6 Participants
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Continuous	49.3 years STANDARD_DEVIATION 6.2 • n=6 Participants
Sex: Female, Male Female	2 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	3 participants n=6 Participants

PRIMARY outcome

Timeframe: 16 weeks

The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity

Outcome measures

Outcome measures
Measure	Subjects with Palmoplantar pustulosis n=2 Participants All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score	0 Participants

PRIMARY outcome

Timeframe: 16 weeks

The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. This second Primary Outcome was added by administrative error since the study only has one Primary Outcome Measure. Hence, the outcome and results are a duplication of the outcome measure reported, and this one was left incomplete in the previous results reporting submission.

Outcome measures

Outcome measures
Measure	Subjects with Palmoplantar pustulosis n=2 Participants All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score	0 Participants

SECONDARY outcome

Timeframe: Week 16, Week 24

The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, Week 24

The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, Week 24

The physician's global assessment is a widely used outcome measure that relies on physician visual assessment of disease severity. The static PGA determines psoriasis severity at a single point in time, without taking the baseline disease condition into clear (0), almost clear (1), mild (2), moderate (3), severe (4).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, Week 24

The EQ-5D is a validated, reliable, and responsive instrument widely used in clinical trials where respondents rate their health in each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, Week 24

The VAS-itch is a 10 cm line on which patients mark their pruritus intensity on a scale from "no itch" (0 points) to "worst imaginable itch" (10 points). The VAS-itch can be interpreted as 0 - \< 3 points represents mild pruritus, ≥ 3 - 7 points moderate pruritus, ≥ 7 - 9 points severe pruritus, and ≥ 9 points severe pruritus

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, 24

The VAS-pain is a 10 cm line on which patients mark their pain on a scale from "no no" (0 points) to "worst imaginable pain" (100 points). The following cut points on the pain VAS have been recommended pain: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75 - 100 mm)

Outcome measures

Outcome data not reported

Adverse Events

Subjects with Palmoplantar pustulosis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects with Palmoplantar pustulosis n=3 participants at risk All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description
Infections and infestations Infection	33.3% 1/3 • Number of events 1 • 24 weeks

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials, Brigham and Women's Hospital Department of Dermatology

Brigham and Women's Hospital

Phone: 617-732-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place