--- title: A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis. nct_id: NCT05689151 overall_status: RECRUITING sponsor: Pfizer study_type: OBSERVATIONAL primary_condition: Atopic Dermatitis countries: France canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05689151.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05689151" ct_last_update_post_date: 2025-12-08 last_seen_at: "2026-05-12T06:23:57.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis. **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. **NCT ID:** [NCT05689151](https://clinicaltrials.gov/study/NCT05689151) ## Key Facts - **Status:** RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 183 - **Lead Sponsor:** Pfizer - **Conditions:** Atopic Dermatitis, Eczema - **Start Date:** 2023-03-09 - **Completion Date:** 2027-12-31 - **CT.gov Last Update:** 2025-12-08 ## 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). ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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). ``` ## Interventions - **Abrocitinib** (DRUG) — Study Drug for Observational Data Collection ## Primary 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: 16 weeks)_ ## 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)_ ## Locations (30) - CHU Amiens-Picardie - Site Nord, Amiens, Somme, France — _RECRUITING_ - CHU Besancon - Hopital Jean Minjoz, Besançon, France — _RECRUITING_ - Polyclinique Reims Bezannes, Bezannes, France — _RECRUITING_ - Chu Bordeaux Hopital Saint Andre, Bordeaux, France — _RECRUITING_ - CHU Brest Hopital Morvan, Brest, France — _RECRUITING_ - CHU de Caen, Caen, France — _RECRUITING_ - Ch de Calais, Calais, France — _RECRUITING_ - Ch William Morey, Chalon-sur-Saône, France — _RECRUITING_ - CHU Clermont Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand, France — _RECRUITING_ - Chu Estaing, Clermont-Ferrand, France — _RECRUITING_ - Hopital Henri Mondor, Créteil, France — _RECRUITING_ - Chu Dijon, Dijon, France — _RECRUITING_ - Hopital Franco Britannique, Levallois-Perret, France — _RECRUITING_ - Hopital Claude Huriez, Lille, France — _RECRUITING_ - CH de Martigues, Martigues, France — _RECRUITING_ - CHU Montpellier, Montpellier, France — _RECRUITING_ - Hopital Emile Muller, Mulhouse, France — _RECRUITING_ - Hopital Hotel Dieu, Nantes, France — _RECRUITING_ - Hopital Cochin, Paris, France — _RECRUITING_ - Hopital Tenon, Paris, France — _RECRUITING_ - Hopital Saint Louis (APHP) - Service Hematologic Senior, Paris, France — _RECRUITING_ - CHU Lyon Sud, Pierre-Bénite, France — _RECRUITING_ - Hopital Pontchaillou, Rennes, France — _RECRUITING_ - Ch de Romans Sur Isere, Romans-sur-Isère, France — _RECRUITING_ - Hopital Charles Nicolle, Rouen, France — _RECRUITING_ - Chi Poissy Saint Germain En Laye, Saint-Germain-en-Laye, France — _RECRUITING_ - Hopital Bégin, Saint-Mandé, France — _RECRUITING_ - Hopital Larrey, Toulouse, France — _RECRUITING_ - Ch de Valenciennes, Valenciennes, France — _RECRUITING_ - CHU Nancy, Vandœuvre-lès-Nancy, France — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.chu amiens-picardie - site nord|amiens|somme|france` — added _(2026-05-12)_ - `locations.chu besancon - hopital jean minjoz|besançon||france` — added _(2026-05-12)_ - `locations.polyclinique reims bezannes|bezannes||france` — added _(2026-05-12)_ - `locations.chu bordeaux hopital saint andre|bordeaux||france` — added _(2026-05-12)_ - `locations.chu brest hopital morvan|brest||france` — added _(2026-05-12)_ - `locations.chu de caen|caen||france` — added _(2026-05-12)_ - `locations.ch de calais|calais||france` — added _(2026-05-12)_ - `locations.ch william morey|chalon-sur-saône||france` — added _(2026-05-12)_ - `locations.chu clermont ferrand - hopital gabriel montpied|clermont-ferrand||france` — added _(2026-05-12)_ - `locations.chu estaing|clermont-ferrand||france` — added _(2026-05-12)_ - `locations.hopital henri mondor|créteil||france` — added _(2026-05-12)_ - `locations.chu dijon|dijon||france` — added _(2026-05-12)_ - `locations.hopital franco britannique|levallois-perret||france` — added _(2026-05-12)_ - `locations.hopital claude huriez|lille||france` — added _(2026-05-12)_ - `locations.ch de martigues|martigues||france` — added _(2026-05-12)_ - `locations.chu montpellier|montpellier||france` — added _(2026-05-12)_ - `locations.hopital emile muller|mulhouse||france` — added _(2026-05-12)_ - `locations.hopital hotel dieu|nantes||france` — added _(2026-05-12)_ - `locations.hopital cochin|paris||france` — added _(2026-05-12)_ - `locations.hopital tenon|paris||france` — added _(2026-05-12)_ - `locations.hopital saint louis (aphp) - service hematologic senior|paris||france` — added _(2026-05-12)_ - `locations.chu lyon sud|pierre-bénite||france` — added _(2026-05-12)_ - `locations.hopital pontchaillou|rennes||france` — added _(2026-05-12)_ - `locations.ch de romans sur isere|romans-sur-isère||france` — added _(2026-05-12)_ - `locations.hopital charles nicolle|rouen||france` — added _(2026-05-12)_ - `locations.chi poissy saint germain en laye|saint-germain-en-laye||france` — added _(2026-05-12)_ - `locations.hopital bégin|saint-mandé||france` — added _(2026-05-12)_ - `locations.hopital larrey|toulouse||france` — added _(2026-05-12)_ - `locations.ch de valenciennes|valenciennes||france` — added _(2026-05-12)_ - `locations.chu nancy|vandœuvre-lès-nancy||france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05689151.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05689151* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*