An observational study in Atopic Dermatitis and Eczema, sponsored by Pfizer. Recruiting at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Pfizer · Observational
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).
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 183 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Drug for Observational Data Collection
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
Time frame: 16 weeks
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
Time frame: 12, 18 and 24 months
Change in Eczema Area and Severity Index (EASI) score from baseline
Time frame: 16 weeks and at 12, 18, and 24 months
Proportion of patients with an EASI75 and EASI90
Time frame: at 16 weeks and at 12, 18, and 24 months
Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)
Time frame: at 2, 16 weeks
PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)
Time frame: at 2, 16, 24 weeks and at 12 months
Absolute change from baseline in PP-NRS score
Time frame: at 2, 16, and 24 weeks, and at 12 months
Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score
Time frame: at 16 and 24 weeks, and at 12, 18, and 24 months
Absolute changes from baseline score of Epworth sleepiness scale
Time frame: at 2, 16, and 24 weeks, and at 12 months
Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks
Time frame: at 24 weeks and at 12 months
Duration of Drug Therapy
Time frame: Baseline to 24 months
Duration of each dosage
Time frame: Baseline to 24 months
Proportion of patients with each regimen and changes over the treatment period
Time frame: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation
Time frame: Baseline to 24 months
Proportion of patient with permanent treatment discontinuation with reason
Time frame: Baseline up to 24 months
Proportion of Participants Receiving Subsequent Treatment
Time frame: Baseline to 24 months
Number of Participants With Any Changes in Dosing
Time frame: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation with reason
Time frame: Baseline to 24 months
Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)
Time frame: 16 and 24 weeks, and at 12 months
Demographic Characteristic of Participants: Age
Time frame: Baseline
Demographical Characteristics of Participants:sex
Time frame: Baseline
Demographic Characteristic of Participants: Body Mass Index
Time frame: Baseline
Disease Characteristics of Participants: IGA score
Time frame: Baseline
Disease Characteristics of Participants: EASI score
Time frame: Baseline
Disease Characteristics of Participants: % of BSA involvement
Time frame: Baseline
Disease Characteristics of Participants: PRO data
Time frame: Baseline
Demographic Characteristics of Participants: history of treatment for atopic dermatitis
Time frame: Baseline
Disease Characteristics of Participants: history of the disease
Time frame: baseline
Demographic Characteristic of Participants: Comorbidities
Time frame: Baseline
Hematological and lipid biological parameters
Time frame: At baseline and 16 weeks
Proportion of patients with serious events
Time frame: at 16 weeks, 12,18,24 months
Proportion of patients with non-serious adverse events
Time frame: at 16 weeks, 12,18,24 months
Number of scratching episodes during the evening sleep period that occur pre treatment versus on treatment
Data collection (scratch and sleep) from accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Duration of time scratching during the evening sleep period that occur pre treatment versus on treatment
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of sleep quantity
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Total sleep opportunity
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Sleep efficiency
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Total time asleep
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Sleep onset latency
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Wake after sleep onset and Number of wake bouts
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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