A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis. (NCT05689151) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
France183 participantsStarted 2023-03-09
Plain-language summary
The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin.
This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib.
All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time.
We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD.
Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients older than 18 years of age at inclusion.
* Patients with clinical diagnosis of moderate-to-severe chronic atopic dermatitis (also referred to as atopic eczema) at inclusion according to the investigator and eligible for abrocitinib according to its marketing approval.
* Patients that have been informed of the study procedures and have signed the consent.
Exclusion Criteria:
* Patients for whom abrocitinib is contraindicated.
* Patients unable to follow and respect the study procedures and judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons.
* Patients not affiliated to the French social security system.
* Patients deprived of liberty, under guardianship, or unable to provide oral consent.
* Patients participating in a clinical study assessing a medicinal treatment (patients can participate in registries and observatories).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is described as 'Phase NA' — what does that mean for what's already known about abrocitinib's safety and effectiveness, and how does that affect whether it might be right for me?
2The trial is measuring whether patients reach an IGA score of 0 or 1, meaning 'clear' or 'almost clear' skin — based on what you know about abrocitinib so far, how realistic is that level of improvement for someone with my degree of atopic dermatitis?
3Since the study is actively recruiting right now, what would my actual treatment schedule and visit commitments look like, and is that manageable given my daily life?
4Before considering this trial, should I try any approved standard treatments for moderate to severe atopic dermatitis first, or is there a reason joining this study now might make more sense for my situation?
5Are there any specific risks or side effects associated with abrocitinib that I should weigh carefully before deciding whether to discuss enrollment with the study team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points