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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Drug: Abrocitinib

• Study Type: Observational
• Enrollment (Estimated): 183

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• France
  • Besancon, France, 25000
    • Recruiting
    • CHU Besançon - Hôpital Jean Minjoz
  • Chalon Sur Saone, France, 71100
    • Recruiting
    • CH William Morey
  • Clermont Ferrand Cedex 1, France, 63003
    • Recruiting
    • CHU Estaing
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon
  • Lille, France, 59000
    • Recruiting
    • Hopital Claude Huriez
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat
  • Paris CEDEX 10, France, 75475
    • Recruiting
    • Hopital Saint Louis (APHP) - Service Hematologic Senior
  • Pierre-Bénite, France, 69495
    • Recruiting
    • CHU Lyon Sud
  • Saint-Mande, France, 94160
    • Recruiting
    • Hopital Bégin
  • Somme
    • Amiens, Somme, France, 80080
      • Recruiting
      • CHU Amiens-Picardie - Site Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	Data collection (scratch and sleep) from accelerometer monitor	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	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	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	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	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	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	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	At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: dermatology; France; Atopic dermatitis; AD; Eczema; Dermatitis; Abrocitinib; JAK inhibitors; Inflammatory disease; Atopic
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: B7451096; ADAIR (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No