Abrocitinib for Chronic Hand Eczema

Not currently recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called abrocitinib (also known as Cibinqo) for individuals with moderate to severe chronic hand eczema. Researchers aim to determine if abrocitinib is safe and effective in improving eczema symptoms and will assess its effects on the skin using a simple tape method. Participants may receive either a placebo (a pill with no active medicine) or abrocitinib at different doses. Candidates may qualify if they have had stubborn hand eczema for at least six months that hasn't improved with other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that abrocitinib has been tested for safety in people with skin conditions like eczema. In these studies, patients using abrocitinib experienced clearer skin and less itchiness, suggesting its effectiveness in treating skin issues.

However, like all medicines, it carries some risks. Common side effects include nausea, headaches, and acne, which were usually mild and manageable. Serious side effects were rare.

This trial is in an early stage, aiming to gather more information on the safety and tolerability of abrocitinib. While some safety information is available, more research is needed for a complete understanding.

Prospective participants should discuss the potential risks and benefits with the study team or their doctor before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Researchers are excited about abrocitinib for chronic hand eczema because it offers a targeted approach by inhibiting Janus kinase 1 (JAK1), a key player in the inflammatory process that underlies eczema. Unlike traditional treatments like topical corticosteroids or calcineurin inhibitors, abrocitinib is an oral medication, making it a convenient option for patients. Additionally, the trial explores two different doses (100 mg and 200 mg), providing insights into its effectiveness and safety at varying levels. This could potentially lead to a more personalized treatment strategy for those suffering from this persistent condition.

What evidence suggests that abrocitinib could be an effective treatment for chronic hand eczema?

Research has shown that abrocitinib can help treat atopic dermatitis, which resembles chronic hand eczema. Studies have found that abrocitinib can quickly clear the skin and reduce itching for people with these conditions. It is particularly effective for cases that are difficult to treat or frequently recur. Patients who experienced less itching early with abrocitinib often achieved better results later. This trial will evaluate different dosing regimens of abrocitinib, including 100 mg and 200 mg doses, as well as a placebo followed by abrocitinib. Overall, this suggests that abrocitinib could greatly benefit those with chronic hand eczema. ^{2 3 4 6 7}

Who Is on the Research Team?

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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, 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06283550

Study Details | NCT06283550 | Efficacy, Safety, and ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863496/

Real-world Experience of Abrocitinib Treatment in Patients ... This study showed that abrocitinib can be an effective treatment for patients with atopic dermatitis, including those with previous inadequate response to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03720470

NCT03720470 | Study Evaluating Efficacy and Safety of PF ... Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11181921/

Real-world Experience of Abrocitinib on Difficult-to-treat ... Abrocitinib, and other JAK inhibitors, seems not only to treat atopic HE, but also has a remarkable therapeutic effect on recurrent vesicular HE, and even on ...

5. cibinqo.com cibinqo.com/study-results

Study Results for CIBINQO® (abrocitinib) | Safety Info Clinical studies showed that with CIBINQO, clearer skin and fast itch relief could be achieved. Take a look at the results below.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03575871

NCT03575871 | Study Evaluating Efficacy and Safety of PF ... The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks ...

7. ema.europa.eu ema.europa.eu/nl/media/53595

Cibinqo, INN-abrocitinib - EMA There is limited long term safety in abrocitinib clinical studies. ... severe atopic dermatitis and inadequate response to topical corticosteroids: results from.