Abrocitinib for Chronic Hand Eczema

Recruiting at 3 trial locations

Overseen By Rosanna Ottoni, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Innovaderm Research Inc.

Must not be taking: Biological agents, Topical treatments

Disqualifiers: Psoriasis, Cancer, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.

Do I need to stop my current medications to join the trial?

The trial requires you to stop using any topical treatments that could affect chronic hand eczema at least 2 weeks before starting the study. This includes topical corticosteroids, retinoids, and other similar treatments. The protocol does not specify about other medications, so it's best to discuss with the study team.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical treatments that could affect chronic hand eczema at least 2 weeks before starting the study. This includes treatments like topical corticosteroids, retinoids, and other similar medications.

What data supports the idea that Abrocitinib for Chronic Hand Eczema is an effective drug?

The available research shows that Abrocitinib is effective for treating moderate-to-severe atopic dermatitis, a condition similar to chronic hand eczema. Studies have shown that Abrocitinib provides meaningful improvements in symptoms and quality of life for patients with atopic dermatitis. Although specific data for chronic hand eczema is not provided, the success in treating atopic dermatitis suggests potential effectiveness for hand eczema as well. Additionally, JAK inhibitors, the class of drugs to which Abrocitinib belongs, are emerging as promising treatments for hand eczema, indicating that Abrocitinib could be a beneficial option. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Abrocitinib for treating chronic hand eczema?

Abrocitinib has been shown to improve symptoms in people with moderate-to-severe atopic dermatitis, a condition similar to hand eczema, by targeting specific pathways in the immune system. This suggests it might also be effective for hand eczema, as both conditions share underlying mechanisms. ^{1 2 3 4 5}

What safety data exists for Abrocitinib?

Abrocitinib, also known as Cibinqo or PF-04965842, has been evaluated for safety in several clinical trials for moderate-to-severe atopic dermatitis. It was found to be well tolerated in a phase 3 monotherapy trial. An integrated safety analysis from phase II and phase III trials confirmed its safety profile as an oral, once-daily JAK1-selective inhibitor. ^{1 2 4 6 7}

Is Abrocitinib safe for humans?

Abrocitinib has been shown to be well tolerated in clinical trials for moderate-to-severe atopic dermatitis, meaning it generally did not cause serious side effects in those studies. ^{1 2 4 6 7}

Is the drug Abrocitinib a promising treatment for chronic hand eczema?

Abrocitinib is a promising drug because it has been effective in treating moderate-to-severe atopic dermatitis, a condition similar to chronic hand eczema. It has been approved in several countries and has shown positive results in clinical trials, making it a hopeful option for patients. ^{1 4 6 8 9}

How is the drug Abrocitinib different from other treatments for chronic hand eczema?

Abrocitinib is unique because it is an oral medication that specifically inhibits Janus kinase 1 (JAK1), which is a different mechanism of action compared to other treatments for skin conditions. This makes it potentially effective for patients who have not responded well to other therapies. ^{1 4 6 8 9}

Research Team

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Eligibility Criteria

This trial is for people with moderate to severe chronic hand eczema that hasn't improved with corticosteroid treatments. Participants should have a stable condition and not be planning to change their usual medication routines during the trial.

Inclusion Criteria

Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration

Subjects must be willing to comply with all study procedures and must be available for the duration of the study

I am a woman who can have children and have had negative pregnancy tests.

Exclusion Criteria

Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study

Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1

I have had cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Placebo will be orally administered once daily for 16 weeks

16 weeks

Visits at weeks 2, 4, 12, and 16

Treatment Part B

Abrocitinib 200 mg will be orally administered once daily for 16 weeks

16 weeks

Visits at weeks 2, 4, 12, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abrocitinib

Trial Overview The study tests abrocitinib, an oral medication, at two different doses (100 mg and 200 mg) compared to a placebo. It measures how well the drug works, its safety, and how tolerable it is for patients with hand eczema.

Participant Groups

Group I: Abrocitinib 200 mg Experimental Treatment 1 Intervention

Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.

Group II: Abrocitinib 100 mg Experimental Treatment 1 Intervention

Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.

Group III: Placebo then abrocitinib Placebo Group 2 Interventions

Placebo will be orally administered once daily for 16 weeks (Part A) then abrocitinib 200 mg will be orally administered once daily for 16 weeks (Part B).

Abrocitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Cibinqo for:

• Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Approved in United States as Cibinqo for:

• Refractory, moderate-to-severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable

Who Is Running the Clinical Trial?

Innovaderm Research Inc.

Lead Sponsor

Trials

49

Recruited

3,200+

Findings from Research

In a phase 3 study, abrocitinib demonstrated high efficacy in treating moderate-to-severe atopic dermatitis, achieving over 75% improvement in skin severity for 93.5% of prior dupilumab responders and 80.0% of nonresponders after 12 weeks.

The safety profile of abrocitinib was favorable, with fewer cases of conjunctivitis compared to prior dupilumab treatment, although common side effects included nasopharyngitis and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). Shi, VY., Bhutani, T., Fonacier, L., et al.[2022]

In a pooled analysis of 942 patients from three clinical trials, abrocitinib treatment significantly improved signs and symptoms of moderate-to-severe atopic dermatitis compared to placebo, with many patients achieving higher threshold efficacy responses.

Patients who met these higher efficacy thresholds reported greater quality-of-life benefits, indicating that abrocitinib not only alleviates symptoms but also enhances overall well-being in a meaningful way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. Ständer, S., Bhatia, N., Gooderham, MJ., et al.[2022]

Abrocitinib, an oral Janus kinase 1 inhibitor, demonstrated rapid improvement in atopic dermatitis (AD) symptoms, achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) at a median of 29 days for the head and neck region and 30-32 days for other body areas in a phase 3 trial with adult patients.

The treatment showed significant and sustained improvements in AD severity compared to placebo, with effects maintained up to 16 weeks, making it a promising option for patients with difficult-to-treat areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. Alexis, A., de Bruin-Weller, M., Weidinger, S., et al.[2022]

Abrocitinib, an oral JAK1 inhibitor developed by Pfizer, has been approved in the UK and Japan for treating moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older.

The drug has also received a positive opinion from the European Medicines Agency and is under review in several other countries, indicating its potential as a new systemic therapy option for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abrocitinib: First Approval. Deeks, ED., Duggan, S.[2022]

Hand eczema affects about 14.5% of the population and significantly impacts quality of life, leading to missed work and reduced productivity.

Recent advances in treatment, including IL-4/IL-13 inhibitors and JAK inhibitors, show promising efficacy and improved safety profiles, with 56 ongoing clinical trials exploring new pharmacological options for managing hand eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Existing and New Treatments for the Management of Hand Eczema. Ho, JSS., Molin, S.[2023]

In a phase 3 trial involving 391 patients with moderate-to-severe atopic dermatitis, abrocitinib demonstrated significant efficacy, with 38.1% of patients on the 200 mg dose achieving clear or almost clear skin compared to only 9.1% in the placebo group.

Abrocitinib was well tolerated, with serious adverse events occurring in only a small percentage of patients, indicating it is a safe treatment option for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. Silverberg, JI., Simpson, EL., Thyssen, JP., et al.[2021]

Abrocitinib, a JAK1-selective inhibitor, has been shown to have a manageable long-term safety profile for treating moderate-to-severe atopic dermatitis, based on an analysis of 2856 patients over 1614 patient-years.

While some dose-related adverse events like nausea and headache were observed, serious infections and other severe complications were relatively low, indicating that with proper patient selection, abrocitinib can be safely used for extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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, EL., Silverberg, JI., Nosbaum, A., et al.[2022]

In a study of 41 patients with difficult-to-treat moderate-to-severe atopic dermatitis (AD), abrocitinib significantly reduced disease severity over a median follow-up of 25 weeks, with EASI scores improving from 14.7 to 4.0 (p < 0.001).

Despite its effectiveness, 39% of patients discontinued abrocitinib due to ineffectiveness or adverse events, with common side effects including gastrointestinal symptoms (27.6%) and acne (20.7%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. Olydam, JI., Schlösser, AR., Custurone, P., et al.[2023]

In a phase 2b study involving 267 adults with moderate-to-severe atopic dermatitis, abrocitinib (200 mg and 100 mg) showed significant improvements in symptoms and quality of life compared to placebo, with effects observed as early as 2 days after starting treatment.

Patients reported rapid and lasting relief from itching and other symptoms, with notable improvements in various patient-reported outcome measures, indicating that abrocitinib could be an effective treatment option for those inadequately controlled by current therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Simpson, EL., Wollenberg, A., Bissonnette, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). [2022]

2. England pubmed.ncbi.nlm.nih.gov

High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Abrocitinib: First Approval. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Review of Existing and New Treatments for the Management of Hand Eczema. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. [2022]