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Janus Kinase (JAK) Inhibitor

Abrocitinib for Atopic Dermatitis/Eczema (JADE EXTEND Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years

Awards & highlights

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.

Who is the study for?

This trial is for people aged 12+ with moderate to severe atopic dermatitis who've finished a related study. They must not plan to get pregnant, be currently pregnant or breastfeeding, and agree to use contraception if applicable. Participants should avoid sun exposure and certain medications.Check my eligibility

What is being tested?

The trial tests two doses of Abrocitinib (100 mg & 200 mg) taken daily by mouth against a placebo in patients with atopic dermatitis over an initial period of 92 weeks, followed by open-label treatment until the drug's commercial availability or study end.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with oral medications for skin conditions such as digestive issues, skin irritation, headaches, and possibly impacts on growth in adolescents.

JADE EXTEND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in clinical laboratory values

Change from baseline in electrocardiogram (ECG) measurements

Change from baseline in vital signs

+2 more

Secondary outcome measures

Body Surface Area (BSA) affected

Change in height standard deviation score (SDS)

Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)

+10 more

JADE EXTEND Trial Design

2Treatment groups

Experimental Treatment

Group I: Abrocitinib 200 mgExperimental Treatment2 Interventions

Abrocitinib 200 mg QD PO

Group II: Abrocitinib 100 mgExperimental Treatment2 Interventions

Abrocitinib 100 mg QD PO

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abrocitinib 200 mg

2020

Completed Phase 3

~730

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,908,747 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,089,915 Total Patients Enrolled

Media Library

Abrocitinib 100 mg (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03422822 — Phase 3

Atopic Dermatitis Research Study Groups: Abrocitinib 100 mg, Abrocitinib 200 mg

Atopic Dermatitis Clinical Trial 2023: Abrocitinib 100 mg Highlights & Side Effects. Trial Name: NCT03422822 — Phase 3

Abrocitinib 100 mg (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03422822 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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, Washington, and MultiCare Institute for Research and Innovation in Tacoma."

Answered by AI

Recent research and studies

American Journal of Clinical DermatologyJournal

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-severe Atopic Dermatitis from the Phase II and Phase III Clinical Trial Program

Simpson, Eric L., Jonathan I. Silverberg, Audrey Nosbaum, Kevin L. Winthrop, Emma Guttman-Yassky, Karin M. Hoffmeister, Alexander Egeberg, et al.. 2021. “Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-severe Atopic Dermatitis from the Phase II and Phase III Clinical Trial Program”. American Journal of Clinical Dermatology. Springer Science and Business Media LLC. doi:10.1007/s40257-021-00618-3.

American Journal of Clinical DermatologyJournal

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-severe Atopic Dermatitis from the Phase II and Phase III Clinical Trial Program

American Journal of Clinical DermatologyJournal

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-severe Atopic Dermatitis from the Phase II and Phase III Clinical Trial Program

clinicaltrials.govStudy

Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

2018. "Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03422822.