Atopic DermatitisADAIRNCT05689151
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
An observational study of Atopic Dermatitis and Eczema, run by Pfizer at 30 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Abrocitinib
- How many people
- 183 participants
- Where
- 30 sitesFrance
- Study dates
- 9 Mar 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 30 recruiting
- Recruiting
CHU Amiens-Picardie - Site Nord
Amiens, Somme, 80080
- Recruiting
CHU Besancon - Hopital Jean Minjoz
Besançon, 25000
- Recruiting
Polyclinique Reims Bezannes
Bezannes, 51430
- Recruiting
Chu Bordeaux Hopital Saint Andre
Bordeaux, 33075
- Recruiting
CHU Brest Hopital Morvan
Brest, 29609
- Recruiting
CHU de Caen
Caen, 14033
- Recruiting
Ch de Calais
Calais, 62107
- Recruiting
Ch William Morey
Chalon-sur-Saône, 71100
- Recruiting
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, 63000
- Recruiting
Chu Estaing
Clermont-Ferrand, 63003
- Recruiting
Hopital Henri Mondor
Créteil, 94010
- Recruiting
Chu Dijon
Dijon, 21000
- Recruiting
Hopital Franco Britannique
Levallois-Perret, 92300
- Recruiting
Hopital Claude Huriez
Lille, 59000
- Recruiting
CH de Martigues
Martigues, 13698
- Recruiting
CHU Montpellier
Montpellier, 34295
- Recruiting
Hopital Emile Muller
Mulhouse, 68070
- Recruiting
Hopital Hotel Dieu
Nantes, 44000
- Recruiting
Hopital Cochin
Paris, 75014
- Recruiting
Hopital Tenon
Paris, 75020
- Recruiting
Hopital Saint Louis (APHP) - Service Hematologic Senior
Paris, 75475
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
- Recruiting
Hopital Pontchaillou
Rennes, 35033
- Recruiting
Ch de Romans Sur Isere
Romans-sur-Isère, 26102
- Recruiting
Hopital Charles Nicolle
Rouen, 76031
- Recruiting
Chi Poissy Saint Germain En Laye
Saint-Germain-en-Laye, 78105
- Recruiting
Hopital Bégin
Saint-Mandé, 94160
- Recruiting
Hopital Larrey
Toulouse, 31000
- Recruiting
Ch de Valenciennes
Valenciennes, 59322
- Recruiting
CHU Nancy
Vandœuvre-lès-Nancy, 54511
About this study
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.
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.
Read more
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).
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Abrocitinib
- Keywords
- Atopic dermatitis, AD, Eczema, Abrocitinib, JAK inhibitors, France, Dermatitis, Atopic, Inflammatory disease, dermatology
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Study Drug for Observational Data Collection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (39)
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
Measured: 12, 18 and 24 months
Change in Eczema Area and Severity Index (EASI) score from baseline
Measured: 16 weeks and at 12, 18, and 24 months
Proportion of patients with an EASI75 and EASI90
Measured: 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)
Measured: at 2, 16 weeks
PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)
Measured: at 2, 16, 24 weeks and at 12 months
Absolute change from baseline in PP-NRS score
Measured: at 2, 16, and 24 weeks, and at 12 months
Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score
Measured: at 16 and 24 weeks, and at 12, 18, and 24 months
Absolute changes from baseline score of Epworth sleepiness scale
Measured: 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
Measured: at 24 weeks and at 12 months
Duration of Drug Therapy
Measured: Baseline to 24 months
Duration of each dosage
Measured: Baseline to 24 months
Proportion of patients with each regimen and changes over the treatment period
Measured: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation
Measured: Baseline to 24 months
Proportion of patient with permanent treatment discontinuation with reason
Measured: Baseline up to 24 months
Proportion of Participants Receiving Subsequent Treatment
Measured: Baseline to 24 months
Number of Participants With Any Changes in Dosing
Measured: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation with reason
Measured: Baseline to 24 months
Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)
Measured: 16 and 24 weeks, and at 12 months
Demographic Characteristic of Participants: Age
Measured: Baseline
Demographical Characteristics of Participants:sex
Measured: Baseline
Demographic Characteristic of Participants: Body Mass Index
Measured: Baseline
Disease Characteristics of Participants: IGA score
Measured: Baseline
Disease Characteristics of Participants: EASI score
Measured: Baseline
Disease Characteristics of Participants: % of BSA involvement
Measured: Baseline
Disease Characteristics of Participants: PRO data
Measured: Baseline
Demographic Characteristics of Participants: history of treatment for atopic dermatitis
Measured: Baseline
Disease Characteristics of Participants: history of the disease
Measured: baseline
Demographic Characteristic of Participants: Comorbidities
Measured: Baseline
Hematological and lipid biological parameters
Measured: At baseline and 16 weeks
Proportion of patients with serious events
Measured: at 16 weeks, 12,18,24 months
Proportion of patients with non-serious adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689151
- Sponsor's protocol ID
- B7451096
- Other IDs
- ADAIR
- Acronym
- ADAIR
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05689151
- Acronym / sponsor ID
- ADAIR / B7451096
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic dermatitis, AD, Eczema, Abrocitinib, JAK inhibitors, France, Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibStudy Drug for Observational Data Collection | Drug | – |
Primary outcome
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
39 secondary outcomes
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
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
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
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
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
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
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
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
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Eczema, run by Pfizer at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.