Long-term effectiveness of dupilumab for atopic dermatitis in patients aged 6 and older
Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)
This study is testing how well dupilumab works for people aged 6 and older with atopic dermatitis over time and looking at their experiences and health conditions while using the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 55 sites (Aachen and 54 other locations) |
| Trial ID | NCT06039241 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the real-world effectiveness of dupilumab in patients aged 6 years and older with atopic dermatitis. It aims to characterize the patient population in Germany receiving dupilumab, focusing on their medical history, socio-demographic characteristics, and associated atopic comorbidities. The study will assess therapeutic response rates at 6, 12, and 24 months using questionnaires to measure disease control and quality of life. Additionally, it will analyze the dosing patterns of dupilumab in everyday clinical settings.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 years and older with moderate to severe atopic dermatitis who are starting treatment with dupilumab.
Not a fit: Patients who have contraindications for dupilumab or have been treated with it for more than 7 days will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of dupilumab for managing atopic dermatitis, potentially improving treatment strategies.
How similar studies have performed: Other studies have shown positive outcomes with dupilumab for atopic dermatitis, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients are at least 6 years of age at the baseline visit. * Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics. * Patients or their guardians are able to understand and complete the study-related questionnaires. * Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable. Exclusion Criteria: * Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics. * Patients who have already been treated with dupilumab for more than 7 days. * Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results. * Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Where this trial is running
Aachen and 54 other locations
- Investigational Site Number: 061 — Aachen, Germany (Recruiting)
- Investigational Site Number: 092 — Ahaus, Germany (Recruiting)
- Investigational Site Number: 066 — Andernach, Germany (Recruiting)
- Investigational Site Number: 002 — Berlin, Germany (Recruiting)
- Investigational Site Number: 003 — Berlin, Germany (Recruiting)
- Investigational Site Number: 176 — Berlin, Germany (Recruiting)
- Investigational Site Number: 077 — Berlin, Germany (Recruiting)
- Investigational Site Number: 004 — Berlin, Germany (Recruiting)
- Investigational Site Number: 174 — Berlin, Germany (Recruiting)
- Investigational Site Number: 073 — Berlin, Germany (Recruiting)
- Investigational Site Number: 059 — Braunschweig, Germany (Recruiting)
- Investigational Site Number: 057 — Buxtehude, Germany (Recruiting)
- Investigational Site Number: 028 — Chemnitz, Germany (Recruiting)
- Investigational Site Number: 069 — Cologne, Germany (Recruiting)
- Investigational Site Number: 072 — Dresden, Germany (Recruiting)
- Investigational Site Number: 026 — Dresden, Germany (Recruiting)
- Investigational Site Number: 032 — Düren, Germany (Recruiting)
- Investigational Site Number: 043 — Erlangen, Germany (Recruiting)
- Investigational Site Number: 064 — Essen, Germany (Recruiting)
- Investigational Site Number: 184 — Friedberg, Germany (Recruiting)
- Investigational Site Number: 055 — Gera, Germany (Recruiting)
- Investigational Site Number: 007 — Giessen, Germany (Recruiting)
- Investigational Site Number: 031 — Gladbeck, Germany (Recruiting)
- Investigational Site Number: 078 — Göttingen, Germany (Recruiting)
- Investigational Site Number: 087 — Hamburg, Germany (Recruiting)
- Investigational Site Number: 088 — Hamburg, Germany (Recruiting)
- Investigational Site Number: 020 — Hamburg, Germany (Recruiting)
- Investigational Site Number: 086 — Hamburg, Germany (Recruiting)
- Investigational Site Number: 169 — Heidelberg, Germany (Recruiting)
- Investigational Site Number: 053 — Heilbad Heiligenstadt, Germany (Recruiting)
- Investigational Site Number: 063 — Jülich, Germany (Recruiting)
- Investigational Site Number: 186 — Karlsruhe, Germany (Recruiting)
- Investigational Site Number: 016 — Kiel, Germany (Recruiting)
- Investigational Site Number: 017 — Kiel, Germany (Recruiting)
- Investigational Site Number: 183 — Landsberg, Germany (Recruiting)
- Investigational Site Number: 038 — Langenau, Germany (Recruiting)
- Investigational Site Number: 179 — Leipzig, Germany (Recruiting)
- Investigational Site Number: 178 — Mainz, Germany (Recruiting)
- Investigational Site Number: 185 — Mainz, Germany (Recruiting)
- Investigational Site Number: 014 — Mainz, Germany (Recruiting)
- Investigational Site Number: 013 — Mannheim, Germany (Recruiting)
- Investigational Site Number: 018 — Mölln, Germany (Recruiting)
- Investigational Site Number: 035 — Mönchengladbach, Germany (Recruiting)
- Investigational Site Number: 050 — München, Germany (Recruiting)
- Investigational Site Number: 076 — Neubrandenburg, Germany (Recruiting)
- Investigational Site Number: 045 — Nuremberg, Germany (Recruiting)
- Investigational Site Number: 042 — Nuremberg, Germany (Recruiting)
- Investigational Site Number: 024 — Oelde, Germany (Recruiting)
- Investigational Site Number: 082 — Potsdam, Germany (Recruiting)
- Investigational Site Number: 172 — Remscheid, Germany (Recruiting)
+5 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 1800633-1610
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.