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Study on Abrocitinib for Patients with Moderate to Severe Chronic Hand Eczema Unresponsive to Corticosteroids

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What is this study about?

This clinical trial is focused on studying chronic hand eczema, a skin condition that causes redness, itching, and sometimes blisters on the hands. The trial will evaluate a treatment called abrocitinib, which is a type of medication known as a Janus kinase (JAK)1 inhibitor. This medication is being tested to see if it can help people with moderate to severe chronic hand eczema that has not improved with corticosteroid therapy, a common treatment for this condition.

The purpose of the study is to assess the effectiveness, safety, and tolerability of abrocitinib in treating chronic hand eczema. Participants in the study will be randomly assigned to receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of 32 weeks, during which participants will take the medication or placebo orally in the form of film-coated tablets. Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms.

This trial aims to provide valuable information on whether abrocitinib can be an effective treatment option for those suffering from chronic hand eczema. By participating, individuals will contribute to research that could lead to better management of this challenging skin condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, history of hand eczema, and current condition severity.

Participants must be adults aged 18 or older with moderate to severe chronic hand eczema that has not responded to corticosteroid therapy.

2 initial assessment

An initial assessment is conducted to evaluate the severity of hand eczema using a hand Physician’s Global Assessment (PGA) score.

The assessment ensures the condition is moderate to severe, with a score of 3 or 4.

3 medication administration

Participants receive either abrocitinib or a placebo in the form of 100 mg film-coated tablets.

The medication is taken orally, following the prescribed dosage and schedule.

4 ongoing evaluations

Regular evaluations occur at Weeks 2, 4, 12, and 16 to monitor changes in the condition.

These evaluations include measuring the percent change from baseline in various scores such as hand mTLSS, HESCI, and others.

5 final assessment

At Week 16, a final assessment is conducted to determine the overall efficacy of the treatment.

The primary endpoint is the percent change from baseline in hand mTLSS.

6 safety monitoring

Throughout the study, safety is monitored through vital signs and laboratory tests.

Any adverse events or side effects are recorded and evaluated.

Who Can Join the Study?

  • The patient must be an adult, which means they are 18 years of age or older.
  • The patient should have had moderate to severe chronic hand eczema for at least 6 months before the start of the study. Chronic hand eczema is a long-lasting skin condition that affects the hands.
  • The patient must have refractory hand eczema, which means their hand eczema does not improve with standard treatments.
  • The patient should have moderate to severe chronic hand eczema at the time of screening and on the first day of the study. This is determined by a specific assessment called a hand PGA (Physician’s Global Assessment) with a score of 3 or 4.
  • Women who can have children, or their male partners, must use birth control during the study and for at least 4 weeks after the last dose of the study medication. This should follow local rules and availability of birth control methods for people in clinical trials.

Who Cannot Join the Study?

  • Patients who do not have moderate to severe chronic hand eczema cannot participate. This means if your hand eczema is mild or not chronic, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it usually means you need to be within a certain age group.
  • Patients who are part of a vulnerable population may not be eligible. A vulnerable population can include groups like pregnant women, children, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C. Cracow Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c. Osielsko Poland

Other Sites

Site Name City Country Status
Specderm Poznanska Sp. j. Bialystok Poland
St-Inspire Sp. z o.o. Mikolow Poland
Cmidoex Blxrd Kziscxmecao Pldreqsd Swh z opbv Gdansk Poland
Lwwnbjj Sqsgdbuoafefxed Gkruaws Dcfweiswilvcmco Lublin Poland
Lrieb Crgucv Sfrm dj Tzhhsq Kixmnqtrhir dw Agnyobs Kfugxycf Szczecin Poland
Pwtqpyayq Iqnmnrox Mqjknrtl Migymouhelqv Sgtyh Wyaqosgriqvp I Ayuhphtyuewqk Warsaw Poland
Dqjmijzzwe Scl z ogvg Wroclaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
03.06.2024

Trial locations

Investigated drugs:

Abrocitinib is a medication being studied for its effectiveness in treating moderate to severe chronic hand eczema, especially in patients who have not responded well to corticosteroid treatments. It works by targeting specific pathways in the immune system that are involved in inflammation, potentially reducing the symptoms of eczema such as redness, itching, and swelling.

Chronic Hand Eczema – Chronic hand eczema is a skin condition characterized by inflammation, redness, and itching on the hands. It often results in dry, cracked, and thickened skin, which can be painful and uncomfortable. The condition can be triggered by irritants, allergens, or genetic factors, and it tends to persist over time. Symptoms may fluctuate, with periods of worsening and improvement. Chronic hand eczema can significantly impact daily activities due to discomfort and the visible nature of the condition. It is important to manage triggers and maintain skin care to help control symptoms.

Trial ID:
2023-504539-42-00
Protocol code:
INNO-6052
Trial Phase:
Therapeutic exploratory (Phase II)

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