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Deucravacitinib for Palmoplantar Pustulosis
Study Summary
This trial will assess the safety and effectiveness of a drug (deucravacitinib) for a rare skin condition (PPP) over 24 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 220 Patients • NCT04167462Trial Design
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- 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.
- Group 1: Subjects with Palmoplantar pustulosis
- 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.
- 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
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."
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."
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."
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