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Upadacitinib + Topical Corticosteroids for Eczema (AD Up Trial)
AD Up Trial Summary
This trial is testing a new drug to see if it's effective and safe for treating moderate to severe atopic dermatitis in adolescents and adults.
AD Up Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAD Up Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AD Up Trial Design
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Who is running the clinical trial?
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- I have used a moisturizer twice a day for at least a week.I've tried creams or pills for my skin condition without success.I cannot or do not want to stop my current eczema treatments before the study.I have had chronic eczema for over 3 years.I have severe skin itching and rash covering more than 10% of my body.I have used a moisturizer twice a day for at least a week.I have had chronic eczema for over 3 years.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I do not need medications that are not allowed in the study.I am 12-17 years old and weigh at least 40 kg.I have previously taken a JAK inhibitor medication.I don't have skin conditions that need systemic treatment or could affect atopic dermatitis assessment.
- Group 1: Long-Term Extension
- Group 2: Placebo / Upadacitinib + Topical Corticosteroids
- Group 3: Upadacitinib 15 mg QD + Topical Corticosteroids
- Group 4: Upadacitinib 30 mg QD + Topical Corticosteroids
- 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
Are patients currently being accepted into this trial?
"This study is no longer admitting participants. It was originally posted on 8/9/2018 and last updated on 3/8/2022. However, there are presently 257 studies actively admitting participants with eczema and 21 studies for Topical corticosteroids (TCS) looking for patients."
Are there other research facilities in this town that are also testing this treatment?
"Currently, this study is being conducted out of the Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403 in Québec, Quebec, Tory P Sullivan, MD PA /ID# 201174 in North Miami Beach, Florida, and Clinical Research of West Florida, Inc /ID# 203643 in Clearwater. An additional 75 research sites are located throughout the country."
Are octogenarians able to enroll in this program?
"The age range for this clinical trial is 12 to 75. There are 118 studies specifically designed for children and 200 trials available for seniors."
Does this trial break new ground in the medical community?
"Since 2015, medical researchers have been studying the efficacy of Topical corticosteroids (TCS). In 2015, 1629 patients were involved in a study sponsored by AbbVie. After this initial research was conducted, Topical corticosteroids (TCS) received Phase 3 drug approval. As of now, 21 live studies are being conducted for Topical corticosteroids (TCS), spanning 953 cities and 54 countries."
What are the aims of this clinical research?
"The primary outcome of this trial is the percentage of participants achieving a validated investigator global assessment for atopic dermatitis (vIGA-AD) of 0 or 1 with a reduction from baseline of ≥ 2 points at week 16. Secondary outcomes include adolescents: percentage of participants achieving an EASI 75 response at week 2, which is defined as EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema"
Could I be a subject of this research?
"This medical trial is looking for 968 participants between the ages of 12 and 75 who have eczema. In order to be eligible, participants must also meet the following criteria: They must have a documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR systemic treatment for AD within 6 months prior to Baseline Visit, Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age, Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria., Active"
Are there any harmful side effects associated with using TCS?
"Corticosteroids that are applied topically have shown efficacy in Phase 3 trials and multiple rounds of data support its safety, so it received a score of 3."
What skin conditions are helped by the use of Topical corticosteroids (TCS)?
"Topical corticosteroids (TCS) are most often used on patients that may require systemic therapy. Additionally, this medication can help those suffering from rheumatoid arthritis, methotrexate, and other issues not responding well to conventional treatment plans."
How many people are enrolled in this trial at most?
"Currently, this trial is not looking for new patients. However, there are 257 other clinical trials involving eczema and 21 studies concerning Topical corticosteroids (TCS) that are still recruiting participants."
What other scientific papers exist on the topic of Topical corticosteroids (TCS)?
"At the moment, there are 21 different clinical trials underway that focus on Topical corticosteroids (TCS). Of those, 14 have progressed to Phase 3. Although a majority of these studies originate in Belgrade, Beograd, one can find 3924 locations running similar research worldwide."
Who else is applying?
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