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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
Must not have
Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
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 Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have other skin conditions that could affect the study.
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
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 moreSecondary 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 moreJADE 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and newer systemic agents like Janus Kinase (JAK) inhibitors. Topical corticosteroids reduce inflammation by suppressing the immune response.
Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation and immune activity. JAK inhibitors, like Abrocitinib, target specific pathways involved in the immune response by blocking JAK1, which plays a crucial role in the signaling of various cytokines involved in AD.
This targeted approach can reduce inflammation and itchiness more effectively and with potentially fewer side effects compared to broader immunosuppressive therapies. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on the severity and specific characteristics of their AD.
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Who is running the clinical trial?
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,865,610 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,042,219 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have other skin conditions that could affect the study.I am 12 years or older and meet the weight requirement from a previous study.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Abrocitinib 100 mg
- Group 2: Abrocitinib 200 mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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