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JADE EXTEND Trial Summary
This trial is studying whether a new drug, abrocitinib, is effective and safe for treating atopic dermatitis in patients aged 12 years and older. The trial consists of an initial treatment period of 92 weeks, followed by a secondary treatment period of variable length during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country. There is also a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI.
- Atopic Dermatitis
JADE EXTEND Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowJADE EXTEND Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
JADE EXTEND Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with a medical condition called ovarian failure.You have any serious medical or mental health conditions, including recent thoughts of self-harm, that could make it unsafe or difficult for you to participate in the study.
- Group 1: Abrocitinib 100 mg
- Group 2: Abrocitinib 200 mg
- 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
Have there been any other research studies done that focus on Abrocitinib 100 mg?
"Abrocitinib 100 mg was first studied in 2018 at Vital Prospects Clinical Research Institute, P.C.. To date, there have been 18307 completed trials. There are now 2 live trials being conducted; a significant proportion of which are based in Boca Raton, New York."
What does the FDA's decision on Abrocitinib 100 mg mean for patients?
"Abrocitinib 100mg received a safety score of 3. This is because, as a Phase 3 trial drug, there is both efficacy and safety data available from multiple sources."
Has a similar experiment been conducted before?
"Abrocitinib 100 mg has been researched since 2018, when it was first trialed by Pfizer. 3155 patients participated in the initial study, which resulted in Abrocitinib 100 mg receiving approval for Phase 3 clinical trials. As of now, there are 2 live trials being conducted for this medication across 210 cities and 28 countries."
What purpose does Abrocitinib 100 mg serve?
"Abrocitinib 100 mg can be used as a therapeutic procedure for patients that have failed at least one prior systemic therapy and are candidates for systemic therapy."
How many participants are being allowed into this experiment?
"This specific clinical trial is not currently recruiting patients, however there are 257 other studies involving eczema and two other trials testing Abrocitinib 100 mg that are."
Can people with the condition under study currently enroll in this clinical trial?
"According to the latest information on clinicaltrials.gov, this study is no longer enrolling patients. While it may have been seeking candidates at some point between March 8th 2018 and October 24th 2022, that is not the case now. However, there are 259 other trials that are currently looking for participants."
What are the proposed benefits of participating in this trial?
"The primary outcome of this long-term study will be a change in vital signs from the baseline measurement. This will be assessed over an 8 year period, or until the sponsor terminates the study. Additionally, secondary outcomes including serum Hs-CRP levels, PtGA, and DLQI or CDLQI will also be monitored at scheduled intervals throughout the study."
In how many different geographic areas is this trial being conducted?
"There are 12 total locations enrolling patients for this study, which include Skin Care Research in Boca Raton, New York, Forest Hills Dermatology Group in New York, Washingtone Skin Care Research in Boca Raton, New York, Forest Hills Dermatology Group in New York, Washington, and MultiCare Institute for Research and Innovation in Tacoma."
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