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

Atopic Dermatitis Clinical Trial

— ADAIR  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689151
• Other study ID #: B7451096
• Secondary ID: ADAIR
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: May 31, 2027
• Est. primary completion date: June 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Abrocitinib
Study Drug for Observational Data Collection

Locations

Country	Name	City	State
France	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 Bichat	Paris
France	Hopital Saint Louis (APHP) - Service Hematologic Senior	Paris CEDEX 10
France	CHU Lyon Sud	Pierre-Bénite
France	Hopital Bégin	Saint-Mande

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in Eczema Area and Severity Index (EASI) score from baseline		16 weeks and at 12, 18, and 24 months
Secondary	Proportion of patients with an EASI75 and EASI90		at 16 weeks and at 12, 18, and 24 months
Secondary	Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of =2 points from baseline)		at 2, 16 weeks
Secondary	PP-NRS (response improvement of =2 points or =4 points from baseline)		at 2, 16, 24 weeks and at 12 months
Secondary	Absolute change from baseline in PP-NRS score		at 2, 16, and 24 weeks, and at 12 months
Secondary	Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score		at 16 and 24 weeks, and at 12, 18, and 24 months
Secondary	Absolute changes from baseline score of Epworth sleepiness scale		at 2, 16, and 24 weeks, and at 12 months
Secondary	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
Secondary	Duration of Drug Therapy		Baseline to 24 months
Secondary	Duration of each dosage		Baseline to 24 months
Secondary	Proportion of patients with each regimen and changes over the treatment period		Baseline to 24 months
Secondary	Proportion of patient with temporary treatment discontinuation		Baseline to 24 months
Secondary	Proportion of patient with permanent treatment discontinuation with reason		Baseline up to 24 months
Secondary	Proportion of Participants Receiving Subsequent Treatment		Baseline to 24 months
Secondary	Number of Participants With Any Changes in Dosing		Baseline to 24 months
Secondary	Proportion of patient with temporary treatment discontinuation with reason		Baseline to 24 months
Secondary	Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)		16 and 24 weeks, and at 12 months
Secondary	Demographic Characteristic of Participants: Age		Baseline
Secondary	Demographical Characteristics of Participants:sex		Baseline
Secondary	Demographic Characteristic of Participants: Body Mass Index		Baseline
Secondary	Disease Characteristics of Participants: IGA score		Baseline
Secondary	Disease Characteristics of Participants: EASI score		Baseline
Secondary	Disease Characteristics of Participants: % of BSA involvement		Baseline
Secondary	Disease Characteristics of Participants: PRO data		Baseline
Secondary	Demographic Characteristics of Participants: history of treatment for atopic dermatitis		Baseline
Secondary	Disease Characteristics of Participants: history of the disease		baseline
Secondary	Demographic Characteristic of Participants: Comorbidities		Baseline
Secondary	Hematological and lipid biological parameters		At baseline and 16 weeks
Secondary	Proportion of patients with serious events		at 16 weeks, 12,18,24 months
Secondary	Proportion of patients with non-serious adverse events		at 16 weeks, 12,18,24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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