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Upadacitinib vs Dupilumab for Eczema (Level Up Trial)
Level Up Trial Summary
This trial is comparing 2 drugs to treat moderate to severe atopic dermatitis in adolescents and adults who have not responded to systemic therapy. Side effects and disease activity will be assessed.
Level Up Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLevel Up Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Level Up Trial Design
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- My previous systemic treatment for my condition was not effective.You have had significant issues with using drugs or alcohol in the past 6 months, as determined by the doctor.I have had chronic eczema for over 3 years.You have an average weekly score of 4 or higher on the Worst Pruritus Numerical Rating Scale.My eczema is severe, covering more than 10% of my body.My previous systemic treatment for AD did not work well.I have had an organ transplant and am on ongoing immunosuppressants.I have had chronic eczema for over 3 years.I have had chronic eczema for over 3 years.My eczema is severe, covering more than 10% of my body.My eczema is severe, covering more than 10% of my body.You have an average itch score of 4 or higher per week.
- Group 1: Upadacitinib
- Group 2: Dupilumab followed by Upadacitinib
- 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
Does this research project accept volunteers who are younger than 65 years old?
"To be eligible for this trial, patients must between 12 and 64 years old."
What is the latest regulatory decision on Upadacitinib?
"There is evidence from past clinical trials to support the safety of Upadacitinib, which receives a score of 3."
Is this study taking place at several locations across North America?
"This trial is being conducted at 64 sites around the world, including California Dermatology Institute /ID# 250213 in Thousand Oaks, DermAssociates-Rockville /ID# 250047 in Rockville, and Burke Pharmaceutical Research /ID# 249838 in Hot Springs."
Are people still able to sign up for this research project?
"No, this study is not currently looking for patients. As seen on clinicaltrials.gov, the most recent update to this trial was on November 14th, 2022 and it was first posted January 24th, 2023. Although this particular trial isn't searching for candidates, there are 257 other trials with open recruitment at present."
Who meets the eligibility requirements for participating in this research project?
"This dermatitis clinical trial, which needs to enroll 880 total participants, is currently looking for patients that suffer from the skin condition and are between 12 and 64 years old."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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