What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, including Janus Kinase inhibitors like Abrocitinib, are associated with side effects such as increased risk of infections, headaches, nausea, and elevated liver enzymes. Topical corticosteroids, another common treatment, can lead to skin thinning and burning sensations, while calcineurin inhibitors like tacrolimus and pimecrolimus may cause local irritation and burning. Long-term use of these treatments can also result in systemic effects.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including Janus Kinase (JAK) inhibitors similar to Abrocitinib. One notable example is Dupilumab, an IL-4 receptor alpha antagonist, which has been approved for moderate-to-severe atopic dermatitis. Additionally, other JAK inhibitors like Tofacitinib and Ruxolitinib have shown promise in clinical trials for atopic dermatitis, although their primary approvals are for other conditions such as rheumatoid arthritis and myelofibrosis, respectively. These treatments work by modulating the immune response, thereby reducing inflammation and symptoms associated with atopic dermatitis.

What other types of research exist?

Promising alternatives to Abrocitinib for atopic dermatitis include Upadacitinib, another JAK inhibitor, which has shown efficacy in clinical trials. Additionally, biologics such as Dupilumab and Tralokinumab have demonstrated significant improvements in managing moderate-to-severe atopic dermatitis.

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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

Pivotal Trial

Summary

This trial is testing a pill called Abrocitinib to help people aged 12 and older with severe eczema. It aims to see if the pill can reduce inflammation and itching by blocking certain body chemicals. The study includes patients who have already participated in a related study.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in clinical laboratory values

Change from baseline in electrocardiogram (ECG) measurements

Change from baseline in vital signs

+2 more

Secondary study objectives

Body Surface Area (BSA) affected

Change in height standard deviation score (SDS)

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

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Placebo

1995

Completed Phase 3

~2670

Abrocitinib 100 mg

2022

Completed Phase 3

~200

Abrocitinib 200 mg

2022

Completed Phase 3

~930

0 / 1Eligibility criteria met

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.