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.
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.12468
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.45679
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.13467
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.
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
I am 18 years old or older.
I am a woman who can have children and have had negative pregnancy tests.
I have had severe hand eczema for at least 6 months.
My hand eczema has not improved with treatment.
My hand eczema is moderate to severe, as confirmed by a doctor.
Exclusion Criteria
I have had cancer before.
I haven't taken any experimental or approved biological drugs recently.
I have an active skin infection on my hands.
I have had eczema herpeticum recently or multiple times before.
I have a history of blood clotting or platelet issues.
I currently have, or recently had, a serious infection.
I have or have had psoriasis.
I have a history of serious heart problems.
I am currently breastfeeding, pregnant, or planning to become pregnant.
Treatment Details
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Abrocitinib 200 mgExperimental Treatment1 Intervention
Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.
Group II: Abrocitinib 100 mgExperimental Treatment1 Intervention
Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.
Group III: Placebo then abrocitinibPlacebo Group2 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
INNO-6052 Site 12Fredericton, Canada
INNO-6052 Site 13Cobourg, Canada
INNO-6052 Site 11Montréal, Canada
Innovaderm Research Inc.Montréal, Canada
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Who is running the clinical trial?
Innovaderm Research Inc.Lead Sponsor
References
Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. [2021]Abrocitinib, an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD).
Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. [2022]Moderate-to-severe atopic dermatitis (AD) is inadequately controlled with current treatments for many patients. Abrocitinib is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of AD.
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]Pivotal phase III studies demonstrated that abrocitinib, an oral, once-daily, JAK1-selective inhibitor, is effective treatment for moderate-to-severe atopic dermatitis (AD) as monotherapy and in combination with topical therapy.
Abrocitinib: First Approval. [2022]Abrocitinib (Cibinqo®) is an oral small-molecule inhibitor of Janus kinase 1 (JAK1) being developed by Pfizer for the treatment of moderate-to-severe atopic dermatitis (AD). In September 2021, abrocitinib was approved in the UK and Japan for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Abrocitinib has also received a positive CHMP opinion in the EU for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Regulatory applications for the drug have also been submitted for review to several other countries, including the USA and Australia. This article summarizes the milestones in the development of abrocitinib leading to this first approval for the treatment of moderate-to-severe AD.
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]Atopic dermatitis (AD) can affect multiple body regions and is especially burdensome when involving exposed skin areas. Rapid, effective treatment of AD across body regions remains an unmet need, particularly for difficult-to-treat areas such as the head and neck area. We investigated the temporal and regional patterns of clinical improvement in AD with the use of abrocitinib, an orally available Janus kinase 1 selective inhibitor under development for the treatment of moderate-to-severe AD.
Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). [2022]Abrocitinib efficacy by prior dupilumab response status in patients with moderate-to-severe atopic dermatitis has not previously been assessed in phase 3 studies.
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]Once-daily abrocitinib treatment provided meaningful improvements in signs and symptoms of moderate-to-severe atopic dermatitis (AD) in randomized controlled studies.
Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. [2023]Abrocitinib is a JAK-1 selective inhibitor registered for the treatment of moderate-to-severe atopic dermatitis (AD). Although efficacy and safety have been shown in phase 3 clinical trials, data on real-world patients with a treatment history of advanced systemics are scarce.
A Review of Existing and New Treatments for the Management of Hand Eczema. [2023]Hand eczema is a chronic condition that affects an estimated 14.5% of the general population. It has severe quality of life ramifications in those that struggle with it, including days missed from work or school, productivity loss and impaired work functioning. For years, the standard of care included topical moisturizing creams, topical steroids and more recently systemic agents. As new therapeutic targets emerge and recent advances are being developed, it is now more possible than ever that hand eczema can be managed via the underlying mechanisms. A review of the literature was conducted to identify current treatment options for hand eczema and chronic hand eczema. The terms 'hand eczema', 'hand dermatitis' were used to search PubMed, CENTRAL and Embase. To identify new therapies still undergoing investigation, we used the terms 'hand eczema', 'hand dermatitis', 'atopic dermatitis', and 'vesicular eczema of hands and/or feet' to search Clinicaltrials.gov for all studies until December 2022. There were 56 ongoing clinical trials identified for pharmacological treatments for hand eczema on Clinicaltrials.gov from 2000 - 2022, with 16 that are new or ongoing. These included studies for dupilumab, ruxolitinib, delgocitinib (LEO124249), gusacitinib (ASN002), AFX 5931, and roflumilast (ARQ-252). Two major classes of drugs emerging for the treatment of hand eczema include IL-4/IL-13 inhibitors and JAK inhibitors. With the increase in efficacy seen with these new drugs, we are also noting improved adverse effect profiles, making them attractive options to add to a clinician's management toolbox for patients with hand eczema.