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Rilzabrutinib for Eczema
Study Summary
This trial is testing a new drug, rilzabrutinib, for adults with moderate-to-severe atopic dermatitis who haven't responded well to other treatments. The trial will last about 21 weeks and will compare the new drug to a placebo.
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.Trial Design
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- You have been diagnosed with Alzheimer's disease according to the criteria of the American Academy of Dermatology.More than 10% of your body surface area is affected by atopic dermatitis.You must use contraception during the study as required by local regulations.Your eczema is moderate to severe, as measured by a specific score.You have been diagnosed with AD by a doctor and have had it for at least 12 months before starting the study.Your itch intensity score is 4 or higher.You are comfortable with having two pieces of tape placed on your skin to compare how your skin looks before and after treatment.Your itch intensity score at the beginning of the study is 4 or higher.You have taken specific medications for certain medical conditions within the last 3 months.You have been diagnosed with atopic dermatitis according to the American Academy of Dermatology Consensus Criteria.More than 10% of your body surface area is affected by atopic dermatitis at the beginning of the study.You have had a serious infection that needed to be treated with IV medication, or you currently have a moderate to severe infection, including active COVID-19.You cannot start using certain types of moisturizers, topical anesthetics, or antihistamines during the screening period.You have taken corticosteroid pills or injections within the past 4 weeks.You have had phototherapy for atopic dermatitis or used a tanning booth or parlor more than twice a week within the last 4 weeks or will need to use them during the study.You have used certain types of skin medications within one week before the start of the study.Your eczema severity score is 12 or higher at the beginning of the study.Your IGA score is 3 or higher at the beginning of the study.You have not had a good response or could not tolerate a certain type of treatment for your condition in the last 6 months.You have received a COVID-19 vaccine within 14 days before the study starts.You have had a live vaccine within the last 28 days, or plan to get one during the trial, except for the Bacille Calmette Guerin vaccine, which you have had within the last 12 months.Your lab test results are not normal when checked before the study starts.You have a condition that makes you likely to bleed too much.You have taken certain medications that affect the immune system within the last 6 months.You have used proton pump inhibitor drugs like omeprazole or esomeprazole within 3 days before the start of the study. If needed, you can switch to a different type of medication called H2 receptor blockers before the study starts.You are taking certain strong or moderate medications that affect the way the body processes other drugs.You have taken a BTK inhibitor before.You have active tuberculosis (TB) or a history of TB that wasn't fully treated, or you are at high risk for getting TB.You have ongoing severe nausea and vomiting, or have a condition that makes it hard for your body to absorb the study medication.Your acne is rated as severe (IGA score ≥ 3) on a scale from 0 to 4.You have skin conditions like psoriasis or lupus that could affect the study assessments.You have taken certain medications that weaken the immune system within the last 4 weeks.
- Group 1: Rilzabrutinib
- Group 2: Placebo
- 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
Is this study taking place exclusively in the United States?
"To make participation as convenient as possible for patients, this clinical trial has set up 29 sites in locations across the country. If you are interested in enrolling, choose the site that is closest to your location from places like Colorado Springs, Ridgeland and Northridge."
Can anyone enroll in this clinical trial at this time?
"Indeed, the clinical trial is still recruiting patients according to information available on clinicaltrials.gov. This specific study was posted on September 9th, 2021 and edited October 24th, 2022. So far, 136 people have signed up at 29 different locations."
When might the FDA give their okay to Rilzabrutinib?
"While there is some limited data to support Rilzabrutinib's safety, it does not yet have any efficacy data. Therefore, it received a score of 2."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
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