Clinical trial NCT05689151: A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
Official title: Treating Atopic Dermatitis With Abrocitinib and Its Impact in Real Life: An Observational Cohort Study To Describe the Effectiveness of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Eczema
Keywords: Atopic dermatitis
AD
Eczema
Abrocitinib
JAK inhibitors
France
Dermatitis
Atopic
Inflammatory disease
dermatology
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib

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).


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 16 weeks
Secondary outcomes:
measure: 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
timeFrame: 12, 18 and 24 months
measure: Change in Eczema Area and Severity Index (EASI) score from baseline
timeFrame: 16 weeks and at 12, 18, and 24 months
measure: Proportion of patients with an EASI75 and EASI90
timeFrame: at 16 weeks and at 12, 18, and 24 months
measure: Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)
timeFrame: at 2, 16 weeks
measure: PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)
timeFrame: at 2, 16, 24 weeks and at 12 months
measure: Absolute change from baseline in PP-NRS score
timeFrame: at 2, 16, and 24 weeks, and at 12 months
measure: Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score
timeFrame: at 16 and 24 weeks, and at 12, 18, and 24 months
measure: Absolute changes from baseline score of Epworth sleepiness scale
timeFrame: at 2, 16, and 24 weeks, and at 12 months
measure: Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks
timeFrame: at 24 weeks and at 12 months
measure: Duration of Drug Therapy
timeFrame: Baseline to 24 months
measure: Duration of each dosage
timeFrame: Baseline to 24 months
measure: Proportion of patients with each regimen and changes over the treatment period
timeFrame: Baseline to 24 months
measure: Proportion of patient with temporary treatment discontinuation
timeFrame: Baseline to 24 months
measure: Proportion of patient with permanent treatment discontinuation with reason
timeFrame: Baseline up to 24 months
measure: Proportion of Participants Receiving Subsequent Treatment
timeFrame: Baseline to 24 months
measure: Number of Participants With Any Changes in Dosing
timeFrame: Baseline to 24 months
measure: Proportion of patient with temporary treatment discontinuation with reason
timeFrame: Baseline to 24 months
measure: Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)
timeFrame: 16 and 24 weeks, and at 12 months
measure: Demographic Characteristic of Participants: Age
timeFrame: Baseline
measure: Demographical Characteristics of Participants:sex
timeFrame: Baseline
measure: Demographic Characteristic of Participants: Body Mass Index
timeFrame: Baseline
measure: Disease Characteristics of Participants: IGA score
timeFrame: Baseline
measure: Disease Characteristics of Participants: EASI score
timeFrame: Baseline
measure: Disease Characteristics of Participants: % of BSA involvement
timeFrame: Baseline
measure: Disease Characteristics of Participants: PRO data
timeFrame: Baseline
measure: Demographic Characteristics of Participants: history of treatment for atopic dermatitis
timeFrame: Baseline
measure: Disease Characteristics of Participants: history of the disease
timeFrame: baseline
measure: Demographic Characteristic of Participants: Comorbidities
timeFrame: Baseline
measure: Hematological and lipid biological parameters
timeFrame: At baseline and 16 weeks
measure: Proportion of patients with serious events
timeFrame: at 16 weeks, 12,18,24 months
measure: Proportion of patients with non-serious adverse events
timeFrame: at 16 weeks, 12,18,24 months
measure: Number of scratching episodes during the evening sleep period that occur pre treatment versus on treatment
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Duration of time scratching during the evening sleep period that occur pre treatment versus on treatment
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of sleep quantity
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of Total sleep opportunity
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of Sleep efficiency
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of Total time asleep
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of Sleep onset latency
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
measure: Compare change from pre-treatment to on-treatment measures of Wake after sleep onset and Number of wake bouts
timeFrame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie - Site Nord
state: Somme
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz
city: Chalon Sur Saone
country: France
facility: Ch William Morey
city: Clermont Ferrand Cedex 1
country: France
facility: Chu Estaing
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
city: Dijon
country: France
facility: Chu Dijon
city: Lille
country: France
facility: Hopital Claude Huriez
city: Paris CEDEX 10
country: France
facility: Hopital Saint Louis (APHP) - Service Hematologic Senior
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
city: Saint-Mande
country: France
facility: Hopital Bégin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: