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NCT Number: NCT05689151

A Study to Learn About Abrocitinib in Adult 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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie - Site Nord, Amiens, Somme, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Abrocitinib

Drug

Study Drug for Observational Data Collection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Change in Eczema Area and Severity Index (EASI) score from baseline

    Time frame: 16 weeks and at 12, 18, and 24 months

  3. Proportion of patients with an EASI75 and EASI90

    Time frame: at 16 weeks and at 12, 18, and 24 months

  4. Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)

    Time frame: at 2, 16 weeks

  5. PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)

    Time frame: at 2, 16, 24 weeks and at 12 months

  6. Absolute change from baseline in PP-NRS score

    Time frame: at 2, 16, and 24 weeks, and at 12 months

  7. Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score

    Time frame: at 16 and 24 weeks, and at 12, 18, and 24 months

  8. Absolute changes from baseline score of Epworth sleepiness scale

    Time frame: at 2, 16, and 24 weeks, and at 12 months

  9. 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

  10. Duration of Drug Therapy

    Time frame: Baseline to 24 months

  11. Duration of each dosage

    Time frame: Baseline to 24 months

  12. Proportion of patients with each regimen and changes over the treatment period

    Time frame: Baseline to 24 months

  13. Proportion of patient with temporary treatment discontinuation

    Time frame: Baseline to 24 months

  14. Proportion of patient with permanent treatment discontinuation with reason

    Time frame: Baseline up to 24 months

  15. Proportion of Participants Receiving Subsequent Treatment

    Time frame: Baseline to 24 months

  16. Number of Participants With Any Changes in Dosing

    Time frame: Baseline to 24 months

  17. Proportion of patient with temporary treatment discontinuation with reason

    Time frame: Baseline to 24 months

  18. 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

  19. Demographic Characteristic of Participants: Age

    Time frame: Baseline

  20. Demographical Characteristics of Participants:sex

    Time frame: Baseline

  21. Demographic Characteristic of Participants: Body Mass Index

    Time frame: Baseline

  22. Disease Characteristics of Participants: IGA score

    Time frame: Baseline

  23. Disease Characteristics of Participants: EASI score

    Time frame: Baseline

  24. Disease Characteristics of Participants: % of BSA involvement

    Time frame: Baseline

  25. Disease Characteristics of Participants: PRO data

    Time frame: Baseline

  26. Demographic Characteristics of Participants: history of treatment for atopic dermatitis

    Time frame: Baseline

  27. Disease Characteristics of Participants: history of the disease

    Time frame: baseline

  28. Demographic Characteristic of Participants: Comorbidities

    Time frame: Baseline

  29. Hematological and lipid biological parameters

    Time frame: At baseline and 16 weeks

  30. Proportion of patients with serious events

    Time frame: at 16 weeks, 12,18,24 months

  31. Proportion of patients with non-serious adverse events

    Time frame: at 16 weeks, 12,18,24 months

  32. 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

    Data collection (scratch and sleep) from accelerometer monitor

  33. 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

    Measure by accelerometer monitor

  34. 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

    Measure by accelerometer monitor

  35. 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

    Measure by accelerometer monitor

  36. 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

    Measure by accelerometer monitor

  37. 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

    Measure by accelerometer monitor

  38. 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

    Measure by accelerometer monitor

  39. 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

    Measure by accelerometer monitor

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Acronym: ADAIR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 19, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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