What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly Janus Kinase (JAK) inhibitors like Abrocitinib, Baricitinib, and Tofacitinib, have several known side effects. These include nasopharyngitis, headache, and an increased risk of infections due to their immunosuppressive nature. Other potential side effects are gastrointestinal issues, elevated liver enzymes, and changes in blood counts. Long-term safety data is still being evaluated, but these treatments show promise in managing moderate to severe atopic dermatitis.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including Janus Kinase (JAK) inhibitors similar to Abrocitinib. Notably, Upadacitinib and Baricitinib are JAK inhibitors that have shown efficacy in treating moderate-to-severe atopic dermatitis. Additionally, Dupilumab, an IL-4 receptor alpha antagonist, has been widely used for its effectiveness in managing the condition. These treatments represent significant advancements in targeting the underlying inflammatory pathways of atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Abrocitinib for Atopic Dermatitis patients include Delgocitinib, which is approved in Japan for atopic dermatitis and is undergoing clinical development in other countries, and Baricitinib, which has demonstrated efficacy in clinical trials. Additionally, Ruxolitinib cream has shown positive results in phase 2 studies for atopic dermatitis.

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Janus Kinase (JAK) Inhibitor

Abrocitinib for Eczema

Phase 4

Recruiting

Led By Robert Bissonnette, MD

Research Sponsored by Innovaderm Research Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests abrocitinib, a medication taken regularly, on people with atopic dermatitis who didn't respond well to another treatment or have facial redness. It works by reducing inflammation. Abrocitinib is approved in Europe, the United States, and other countries for the treatment of atopic dermatitis in adults whose disease is not controlled with other treatments.

Who is the study for?

This trial is for adults with atopic dermatitis (eczema) who haven't responded well to dupilumab treatment. Participants must have a history of moderate to severe eczema, no significant flare-ups in the last month, and meet specific criteria regarding skin condition severity. Excluded are those with certain immune disorders, cancer within the past 5 years, serious infections or conditions that could affect results.

What is being tested?

The study is testing Abrocitinib's effectiveness on individuals with atopic dermatitis who didn't see improvement after using Dupilumab. It's an open-label trial where all participants know they're receiving Abrocitinib without being compared to a placebo or other drug.

What are the potential side effects?

While not explicitly listed here, potential side effects of Abrocitinib may include nausea, headache, common cold symptoms (nasopharyngitis), and increased risk of infection due to its immune-modulating properties.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 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 of Eczema Area and Severity Index (EASI)

Secondary study objectives

Change from baseline of Body Surface Area (BSA)

Change from baseline of Facial Eczema Area and Severity Index (EASI)

Alzheimer's Disease

+8 more

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT05038982

10%

Folliculitis

10%

Acneiform Eruption

10%

Herpes Labialis

100%

80%

60%

40%

20%

Study treatment Arm

Chronic Pruritus of Unknown Origin

Prurigo Nodularis

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Abrocitinib 100 mg tablet (marketed drug)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abrocitinib

2021

Completed Phase 2

~50

Do I qualify?Apply below to find out

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

Atopic Dermatitis (AD) treatments target the underlying immune dysregulation and skin barrier dysfunction. Janus Kinase (JAK) inhibitors, like Abrocitinib, block the JAK-STAT signaling pathway, reducing inflammation and pruritus by inhibiting cytokines involved in the immune response. Topical corticosteroids reduce inflammation and immune activity by suppressing various inflammatory mediators. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby decreasing inflammation. Biologics like Dupilumab target specific cytokines (IL-4 and IL-13) involved in the inflammatory process. These treatments are crucial for AD patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the root causes of the disease.