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Janus kinase (JAK) inhibitor
Deucravacitinib for Palmoplantar Pustulosis
Phase 4
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate-severe PPP, defined as a ppPASI > 12
Dermatologist confirmed diagnosis of PPP for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16, 24
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a drug (deucravacitinib) for a rare skin condition (PPP) over 24 weeks.
Who is the study for?
Adults over 18 with a dermatologist-confirmed diagnosis of Palmoplantar Pustulosis (PPP) for at least 6 months, who have not seen results from topical treatments and are candidates for systemic or phototherapy. Participants must have moderate to severe PPP and be willing to stop current PPP treatments except OTC emollients.Check my eligibility
What is being tested?
The trial is testing Deucravacitinib, taken daily at a dose of 6 mg for 24 weeks by patients with PPP. The study involves regular visits every four weeks and aims to see how effective this treatment is in managing the condition.See study design
What are the potential side effects?
While specific side effects for Deucravacitinib in this trial aren't listed, common ones may include headaches, nausea, upper respiratory infections, high blood pressure, and potential liver enzyme abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My palmoplantar pustulosis is moderate to severe.
Select...
I have been diagnosed with PPP by a dermatologist for at least 6 months.
Select...
I am willing to stop my current skin treatments, except for over-the-counter moisturizers.
Select...
Creams or ointments didn't work for my condition, and I need stronger treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16, 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16, 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change from baseline in EQ-5D VAS
Change from baseline in ppPASI
Change from baseline in the Dermatology Quality Life Index (DLQI)
+4 moreSide effects data
From 2022 Phase 3 trial • 220 Patients • NCT0416746218%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Week 0 up to Week 16
BMS-986165 Week 0 up to Week 52
BMS-986165 Week 16 up to Week 52
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects with Palmoplantar pustulosisExperimental Treatment1 Intervention
All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,882,269 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,930 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.My palmoplantar pustulosis is moderate to severe.You have very low white blood cell or platelet counts, or low hemoglobin levels, or high liver enzyme levels.I have not received a live vaccine in the last 8 weeks.You have any other infections like tuberculosis, HIV, hepatitis B, or hepatitis C that are not being treated.I have been diagnosed with PPP by a dermatologist for at least 6 months.I am willing to stop my current skin treatments, except for over-the-counter moisturizers.Creams or ointments didn't work for my condition, and I need stronger treatment.You have a long-term medical condition that is not well managed and might make it hard for you to take part in the clinical trial.I am taking medication to suppress my immune system due to another immune condition.I have not had any cancer, except for treated non-melanoma skin cancer, in the last 5 years.I am 18 years old or older.I haven't taken specific medications or treatments for my condition recently.I haven't had a serious infection or needed antibiotics in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with Palmoplantar pustulosis
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned any treatments for Subjects with Palmoplantar pustulosis?
"Due to the status of this Phase 4 trial, our team deems Subjects with Palmoplantar pustulosis as a 3 on a safety scale. This signifies that it has been approved for use and there is ample data supporting its efficacy."
Answered by AI
What is the current size of the cohort involved in this investigation?
"Affirmative. According to the clinicaltrials.gov database, this research initiative is actively recruiting patients - which began on July 1st 2023 and was recently updated on July 25th 2023. 18 individuals are needed from a single medical facility for participation in the trial."
Answered by AI
Is enrollment in this research project still open?
"Affirmative. Clinicaltrials.gov's records imply that this research is still enrolling volunteers, with the trial initially posted on July 1st 2023 and recently updated on July 25th 2023. 18 individuals are needed from one location to take part in the study."
Answered by AI
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