ADAIR: A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05689151

Collaborator

(none)

183

Enrollment

52.7

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Eczema	Drug: Abrocitinib

Study Design

Study Type:

Observational

Anticipated Enrollment :

183 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jan 9, 2023

Anticipated Primary Completion Date :

Jun 5, 2026

Anticipated Study Completion Date :

May 31, 2027

Outcome Measures

Primary Outcome Measures

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

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]
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]
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]
Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score [at 16 and 24 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]
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]
Duration of Drug Therapy [Baseline to 24 months]
Duration of each dosage [Baseline to 24 months]
Proportion of patients with each regimen and changes over the treatment period [Baseline to 24 months]
Proportion of patient with temporary treatment discontinuation [Baseline to 24 months]
Proportion of patient with permanent treatment discontinuation with reason [Baseline up to 24 months]
Proportion of Participants Receiving Subsequent Treatment [Baseline to 24 months]
Number of Participants With Any Changes in Dosing [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]
Demographic Characteristic of Participants: Age [Baseline]
Demographical Characteristics of Participants:sex [Baseline]
Demographic Characteristic of Participants: Body Mass Index [Baseline]
Disease Characteristics of Participants: IGA score [Baseline]
Disease Characteristics of Participants: EASI score [Baseline]
Disease Characteristics of Participants: % of BSA involvement [Baseline]
Disease Characteristics of Participants: PRO data [Baseline]
Demographic Characteristics of Participants: history of treatment for atopic dermatitis [Baseline]
Disease Characteristics of Participants: history of the disease [baseline]
Demographic Characteristic of Participants: Comorbidities [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]
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 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 Total sleep opportunity [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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).