A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
- Conditions
- Atopic DermatitisEczema
- Registration Number
- NCT05689151
- Lead Sponsor
- Pfizer
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 183
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 16 weeks
- Secondary Outcome Measures
Name Time Method Proportion of Participants Receiving Subsequent Treatment Baseline to 24 months Proportion of patient with temporary treatment discontinuation with reason Baseline to 24 months Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale) 16 and 24 weeks, and at 12 months 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 12, 18 and 24 months Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score at 16 and 24 weeks, and at 12, 18, and 24 months Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks at 24 weeks and at 12 months Change in Eczema Area and Severity Index (EASI) score from baseline 16 weeks and at 12, 18, and 24 months Proportion of patients with an EASI75 and EASI90 at 16 weeks and at 12, 18, and 24 months Absolute changes from baseline score of Epworth sleepiness scale at 2, 16, and 24 weeks, and at 12 months Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline) at 2, 16 weeks PP-NRS (response improvement of ≥2 points or ≥4 points from baseline) at 2, 16, 24 weeks and at 12 months Absolute change from baseline in PP-NRS score at 2, 16, and 24 weeks, and at 12 months Proportion of patient with temporary treatment discontinuation Baseline to 24 months Duration of each dosage Baseline to 24 months Duration of Drug Therapy Baseline to 24 months Proportion of patients with each regimen and changes over the treatment period Baseline to 24 months Proportion of patient with permanent treatment discontinuation with reason Baseline up to 24 months Number of Participants With Any Changes in Dosing Baseline to 24 months Disease Characteristics of Participants: IGA score Baseline Demographic Characteristic of Participants: Comorbidities Baseline Demographic Characteristic of Participants: Age Baseline Demographical Characteristics of Participants:sex Baseline Disease Characteristics of Participants: history of the disease baseline Hematological and lipid biological parameters At baseline and 16 weeks Proportion of patients with serious events at 16 weeks, 12,18,24 months Proportion of patients with non-serious adverse events at 16 weeks, 12,18,24 months Demographic Characteristic of Participants: Body Mass Index Baseline Disease Characteristics of Participants: EASI score Baseline Demographic Characteristics of Participants: history of treatment for atopic dermatitis Baseline Disease Characteristics of Participants: % of BSA involvement Baseline Disease Characteristics of Participants: PRO data Baseline Number of scratching episodes during the evening sleep period that occur pre treatment versus on treatment At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Data collection (scratch and sleep) from accelerometer monitor
Duration of time scratching during the evening sleep period that occur pre treatment versus on treatment At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of Total time asleep At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of Sleep onset latency At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of Wake after sleep onset and Number of wake bouts At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of sleep quantity At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of Sleep efficiency At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Compare change from pre-treatment to on-treatment measures of Total sleep opportunity At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib Measure by accelerometer monitor
Trial Locations
- Locations (10)
CHU Amiens-Picardie - Site Nord
🇫🇷Amiens, Somme, France
CHU Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Ch William Morey
🇫🇷Chalon Sur Saone, France
Chu Estaing
🇫🇷Clermont Ferrand Cedex 1, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Chu Dijon
🇫🇷Dijon, France
Hopital Claude Huriez
🇫🇷Lille, France
Hopital Saint Louis (APHP) - Service Hematologic Senior
🇫🇷Paris CEDEX 10, France
CHU Lyon Sud
🇫🇷Pierre-Bénite, France
Hopital Bégin
🇫🇷Saint-Mande, France