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Upadacitinib for Eczema
Study Summary
This trial will test if upadacitinib is an effective and safe treatment for moderate to severe atopic dermatitis in adolescents and adults.
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 2023 Phase 3 trial • 613 Patients • NCT03086343Trial Design
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- I am between 12 and 18 years old and weigh at least 40 kg.My eczema is severe, covering more than 10% of my body and itches intensely.I need or recently needed treatment that affects my whole body for Alzheimer's disease.I have previously taken medication that targets Janus kinase (JAK).I do not need medications that are not allowed in the study.I do not have skin conditions or infections that need strong medication or could affect skin assessments.I am between 12 and 18 years old and weigh at least 40 kg.I have had chronic eczema for over 3 years.My eczema is severe, covering more than 10% of my body and itches intensely.I've tried topical treatments for my skin condition without success or cannot use them due to side effects.I cannot or do not want to stop my current Alzheimer's treatments for this study.I've tried topical treatments for my skin condition without success or cannot use them due to side effects.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I need or recently needed medication for my whole body to treat Alzheimer's disease.I have had chronic eczema for over 3 years.I have had chronic eczema for over 3 years.I need or recently needed medication for my entire body to treat my disease.
- Group 1: Placebo / Upadacitinib
- Group 2: Upadacitinib 15 mg QD
- Group 3: Upadacitinib 30 mg QD
- 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
Does this research involve participants who are above the age of 65?
"The age limit for participants in this trial are 12 years or older but must be younger than 75."
Can you tell me if there is a body of research surrounding Upadacitinib?
"Upadacitinib is being studied in 21 different clinical trials at the moment, 14 of which are Phase 3. The global distribution of these studies suggests that Upadacitinib could be a promising treatment, with 3924 locations running trials for this medication."
Is this research project being conducted in a few hospitals or many hospitals across the state?
"Enrolling patients at 92 different locations, this study is presently underway. Some of these sites are based in Towson, Chicago and Ann Arbor with the remaining 89 clinical trial centres located throughout the United States. If you enroll in this study, it is important to choose a location close to your home to reduce travel burden."
What is the originality of this research?
"Upadacitinib has undergone 21 clinical trials in the 5 years since its initial study in 2015. These trials have taken place across 953 cities and 54 countries, with 1629 patients participating in the first Phase 3 trial sponsored by AbbVie."
What possible side effects could Upadacitinib have on patients?
"Upadacitinib has received a safety score of 3. This is due to the fact that it is a Phase 3 trial, meaning there is clinical evidence supporting its efficacy as well as numerous rounds of data affirming its safety."
Are patients currently being accepted into this trial program?
"As of right now, this study has finished recruiting patients. The information posted on clinicaltrials.gov suggests that the trial was first announced on 7/27/2018 and experienced its most recent edit on 3/1/2022. If you are interested in other studies, know that there are 257 trials for eczema and 21 for Upadacitinib currently underway."
What medical conditions has Upadacitinib been proven to improve?
"Upadacitinib is useful for patients that may require systemic therapy, as well as those dealing with rheumatoid arthritis, methotrexate treatment, and an insufficient response to conventional therapies."
How many people are enrolled in this experiment?
"This study is no longer recruiting patients. The initial posting was on July 27th, 2018 and the most recent update was March 1st, 2022. For those still seeking trials, there are 257 clinical trials for eczema actively enrolling patients and 21 trials for Upadacitinib."
What are researchers hoping to learn from this clinical trial?
"The primary goal of this study, which will be assessed at Week 16, is to determine the percentage of participants who achieve a 75% reduction in eczema severity (as measured by the Eczema Area and Severity Index). Secondary objectives include assessing the percentage of participants who experience an improvement in ADerm-IS emotional state score (defined as a score ≥11 on the MCID scale) from baseline, adolescents: percent change from baseline in SCORAD score at Week 16, and percentage of participants achieving an improvement in Atopic dermatitis Symptom Scale 7-item total symptom score (TSS-7"
How can I apply to participate in this research?
"This study is looking for 912 participants that have eczema, are infantile, and between the ages of 12-75. Key inclusion criteria are as follows: must weigh ≥40kg if under 18 years old, have chronic atopic dermatitis that has shown symptoms for 3+ years & meets Hanifin & Rajka criteria, active moderate to severe AD defined by Eczema Area & Severity Index (EASI) ≥ 16 or validated Investigator's Global Assessment (vIGA) ≥ 3, BSA affected by AD ≥ 10%, and weekly average of daily Worst Pruritus NRS score ≥ 4., be"
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