Learning about Abrocitinib for treating moderate to severe atopic dermatitis in adults
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.
This study is testing if taking Abrocitinib daily can safely help adults with moderate to severe atopic dermatitis feel better over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 183 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | abrocitinib |
| Locations | 30 sites (Amiens, Somme and 29 other locations) |
| Trial ID | NCT05689151 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Abrocitinib in adult patients suffering from moderate to severe atopic dermatitis in a real-world clinical setting. Participants, aged 18 and older, will take Abrocitinib daily while also using topical treatments for their condition. The study will last for 24 months, during which participants will visit the clinic approximately every 4 to 6 months to monitor their experiences and outcomes. The goal is to gather data that will help determine the medicine's safety and its impact on treating atopic dermatitis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a clinical diagnosis of moderate-to-severe chronic atopic dermatitis.
Not a fit: Patients who are contraindicated for Abrocitinib or unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Abrocitinib for patients with atopic dermatitis.
How similar studies have performed: Other studies have shown promising results with JAK inhibitors like Abrocitinib for atopic dermatitis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Amiens, Somme and 29 other locations
- 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)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.