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Clinical Trials in Spain / NCT03992417
Active, not recruiting Observational

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

NCT03992417 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Observational
Started
2019-06-11
Last updated
2026-08-06

Condition(s) studied

Dermatitis Atopic

Investigational drug(s) / intervention(s)

Dupilumab SAR231893 (REGN668) →

Dupilumab SAR231893 (REGN668): Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Study summary

Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD

Secondary Objectives:

* To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
* To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
* To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
* To collect safety data on study participants

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group; * Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index \[EASI\], Scoring of Atopic Dermatitis \[SCORAD\], body surface area \[of AD involvement\] \[BSA\], Patient-Oriented Eczema Measure \[POEM\], and Dermatology Life Quality Index \[DLQI\]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database * Able to understand and complete study-related questionnaires * Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable Exclusion Criteria: * Participants who have a contraindication to the drug according to the country-specific prescribing information label * Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments * Patients currently participating in any interventional clinical trial which modifies patient care * Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

Trial sites (105)

FacilityCityRegionStatus
Investigational Site Number : 0320013 Pilar Buenos Aires
Investigational Site Number : 0320012 Rosario Santa Fe Province
Investigational Site Number : 0320011 Ciudad Autonoma Bs As Argentina
Investigational Site Number : 0360002 Kogarah New South Wales
Investigational Site Number : 0360005 Kogarah New South Wales
Investigational Site Number : 0360003 Woolloongabba Queensland
Investigational Site Number : 0360004 Bedford Park South Australia
Investigational Site Number : 0360001 Carlton Victoria
Investigational Site Number : 0400005 Graz Austria
Investigational Site Number : 0400004 Linz Austria
Investigational Site Number : 0400002 Maria Enzersdorf Austria
Investigational Site Number : 0400001 Vienna Austria
Investigational Site Number : 0560002 Brussels Belgium
Investigational Site Number : 0560007 Edegem Belgium
Investigational Site Number : 0560010 Ghent Belgium
Investigational Site Number : 0560003 Jette Belgium
Investigational Site Number : 0560001 Leige Belgium
Investigational Site Number : 0560008 Leuven Belgium
Investigational Site Number : 0560006 Roeselare Belgium
Investigational Site Number : 1700008 Bogotá Colombia
Investigational Site Number : 1700012 Bogotá Colombia
Investigational Site Number : 1700011 Medellín Colombia
Investigational Site Number : 2030008 Hradec Králové Czechia
Investigational Site Number : 2030006 Olomouc Czechia
Investigational Site Number : 2030003 Ostrava - Poruba Czechia
Investigational Site Number : 2030004 Pilsen Czechia
Investigational Site Number : 2030005 Prague Czechia
Investigational Site Number : 2030002 Prague Czechia
Investigational Site Number : 2030001 Ústí nad Labem Czechia
Investigational Site Number : 2460002 Kokkola Finland
Investigational Site Number : 2500011 Antony France
Investigational Site Number : 2500003 Bordeaux France
Investigational Site Number : 2500009 Montpellier France
Investigational Site Number : 2500006 Pierre-Bénite France
Investigational Site Number : 2500010 Rouen France
Investigational Site Number : 2500005 Saint-Mandé Cedex France
Investigational Site Number : 2500002 Toulouse France
Investigational Site Number : 2500001 Valence France
Investigational Site Number : 3000003 Thessaloniki Greece
Investigational Site Number : 3000001 Thessaloniki Greece

+ 65 more sites — see the full list on the official registry below.

More Sanofi trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03992417 on ClinicalTrials.gov ↗ ← All trials in Spain