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Study on Long-Term Safety and Effectiveness of Abrocitinib for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called Abrocitinib for treating moderate to severe atopic dermatitis, which is a type of eczema that causes itchy and inflamed skin. The study involves participants who are 12 years and older and have previously been part of other studies involving Abrocitinib. The medication is taken in the form of 100 mg or 200 mg film-coated tablets, and participants may also use topical treatments, which are creams or ointments applied directly to the skin, if needed.

The purpose of the study is to gather information on how safe and effective Abrocitinib is when used over a long period. Participants will continue taking the medication they received in earlier studies, and their health will be monitored to check for any side effects or changes in their condition. The study will also look at how the medication affects the severity of the eczema, the amount of skin affected, and the overall quality of life of the participants.

Throughout the study, participants will have regular check-ups to monitor their health, including tests to check their heart and blood, as well as assessments of their skin condition. The study aims to provide valuable information on the long-term use of Abrocitinib for treating atopic dermatitis, helping to understand its benefits and any potential risks associated with its use.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and Initial Assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing previous participation in qualifying studies and ensuring compliance with study requirements.
Participants must have completed the full treatment period of a previous study or meet specific criteria from a related study.
Step 2
Medication Administration
Participants receive either Abrocitinib or a placebo. The medication is administered in the form of a film-coated tablet.
The dosage is either 100 mg or 200 mg, taken once daily by mouth. The duration of this treatment is determined by the study protocol.
Step 3
Use of Topical Medications
If necessary, participants may also use topical medications to manage symptoms of atopic dermatitis.
The use of these medications is monitored and adjusted as needed throughout the study.
Step 4
Regular Monitoring and Assessments
Participants attend scheduled visits for regular monitoring. This includes laboratory tests, vital signs checks, and other assessments to track health and response to treatment.
The study aims to evaluate the long-term safety and effectiveness of the treatment.
Step 5
Completion and Follow-Up
Upon completion of the study period, a final assessment is conducted to evaluate the overall health and treatment outcomes.
Participants may be required to attend follow-up visits to monitor any long-term effects of the treatment.

Who can join the trial?

8 criteria

Must have a signed and dated document showing that you or your parent/legal guardian understand the important details of the study.
Must be a male or female aged 12 years or older. If you are under 18, you can only join if the study sponsor and health authorities allow it.
Must be willing and able to attend scheduled visits, follow the treatment plan, and complete lab tests and other study procedures.
Must have completed the full treatment period of a previous related study or specific parts of it, as required.
If you are a female who can have children (usually aged 12 and older), you must not plan to become pregnant, be currently pregnant, or breastfeeding. You must have a negative pregnancy test before starting the study and agree to use a highly effective birth control method during the study and for at least 28 days after the last dose of the study medication.
If you are a female who cannot have children, you must meet one of the following: have had surgery to remove the uterus or ovaries, have medically confirmed ovarian failure, or have stopped having periods for at least 12 months with a test confirming menopause.
Must agree to avoid long exposure to the sun and not use tanning booths, sun lamps, or other ultraviolet light sources during the study.
Must agree not to use medications that are not allowed during the study.

Who cannot join the trial?

8 criteria

Patients who have not previously participated in qualifying studies for the medication being tested.
Patients who do not have a diagnosis of moderate to severe atopic dermatitis, which is a skin condition causing itchy and inflamed skin.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the effects of the medication on unborn or nursing babies are not known.
Patients who are taking other medications that might interfere with the study medication.
Patients who have a history of allergic reactions to similar medications.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CRU Hungary Kft.
Verified
Encs, Hungary
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland

Trial locations

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Investigated drugs

Abrocitinib is a medication being studied for its effectiveness and safety in treating moderate to severe atopic dermatitis, a type of eczema. It is taken orally and works by targeting specific pathways in the immune system to reduce inflammation and itching associated with the condition. This trial is focused on understanding the long-term safety of abrocitinib when used alone or in combination with topical treatments.

Abrocitinib

What is already known about the treatment

Abrocitinib – This medication is administered orally in tablet form and is currently being studied in clinical trials for its long-term safety and effectiveness in treating moderate to severe atopic dermatitis. It is classified as a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, thereby reducing symptoms of the condition. Abrocitinib is primarily indicated for individuals aged 12 years and older who suffer from this skin disorder. The medication is still under investigation, and its use is being closely monitored in medical studies to ensure its safety and efficacy.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen and then improve. The skin may become dry, cracked, and prone to infections due to constant scratching. Over time, affected areas can thicken and become more leathery. Environmental factors, allergens, and stress can trigger or exacerbate symptoms.