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

July 10, 2025 updated by: Sanofi

A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants enrolled in the study will be followed for 5 years.

Study Type

Observational

Enrollment (Actual)

955

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Bs As, Argentina, C1121ABE
        • Investigational Site Number : 0320011
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Investigational Site Number : 0320013
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DBS
        • Investigational Site Number : 0320012
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Investigational Site Number : 0360002
      • Kogarah, New South Wales, Australia, 2217
        • Investigational Site Number : 0360005
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Investigational Site Number : 0360003
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Investigational Site Number : 0360004
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Investigational Site Number : 0360001
  • Austria
      • Graz, Austria, 8036
        • Investigational Site Number : 0400005
      • Linz, Austria, 4020
        • Investigational Site Number : 0400004
      • Maria Enzersdorf, Austria, 2344
        • Investigational Site Number : 0400002
      • Vienna, Austria, 1220
        • Investigational Site Number : 0400001
  • Belgium
      • Brussels, Belgium, 1200
        • Investigational Site Number : 0560002
      • Edegem, Belgium, 2650
        • Investigational Site Number : 0560007
      • Gent, Belgium, 9000
        • Investigational Site Number : 0560010
      • Jette, Belgium, 1090
        • Investigational Site Number : 0560003
      • Leige, Belgium, 4000
        • Investigational Site Number : 0560001
      • Leuven, Belgium, 3000
        • Investigational Site Number : 0560008
      • Namur, Belgium, 5000
        • Investigational Site Number : 0560004
      • Roeselare, Belgium, 8800
        • Investigational Site Number : 0560006
  • Colombia
      • Bogota, Colombia, 11001
        • Investigational Site Number : 1700008
      • Bogota, Colombia, 110221
        • Investigational Site Number : 1700012
      • Medellín, Colombia, 050034
        • Investigational Site Number : 1700011
  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Investigational Site Number : 2030008
      • Olomouc, Czechia, 77900
        • Investigational Site Number : 2030006
      • Ostrava - Poruba, Czechia, 70852
        • Investigational Site Number : 2030003
      • Plzen, Czechia, 304 60
        • Investigational Site Number : 2030004
      • Praha 1, Czechia, 110 01
        • Investigational Site Number : 2030005
      • Praha 5, Czechia, 150 06
        • Investigational Site Number : 2030002
      • Usti nad Labem, Czechia, 40113
        • Investigational Site Number : 2030001
  • Finland
      • Kokkola, Finland, 67200
        • Investigational Site Number : 2460002
  • France
      • Antony, France, 92160
        • Investigational Site Number : 2500011
      • Auxerre, France, 89000
        • Investigational Site Number : 2500004
      • Bordeaux, France, 33000
        • Investigational Site Number : 2500003
      • Montpellier Cedex 5, France, 34295
        • Investigational Site Number : 2500009
      • Pierre Benite cedex, France, 69495
        • Investigational Site Number : 2500006
      • Rouen, France, 76000
        • Investigational Site Number : 2500010
      • Saint-Mandé Cedex, France, 94160
        • Investigational Site Number : 2500005
      • Toulouse Cedex 9, France, 31059
        • Investigational Site Number : 2500002
      • Valence, France, 26953
        • Investigational Site Number : 2500001
  • Greece
      • Athens, Greece, 16121
        • Investigational Site Number : 3000002
      • Thessaloniki, Greece, 54645
        • Investigational Site Number : 3000003
      • Thessaloniki, Greece, 56403
        • Investigational Site Number : 3000001
  • Israel
      • Afula, Israel, 18101
        • Investigational Site Number : 3760006
      • Haifa, Israel, 3109601
        • Investigational Site Number : 3760001
      • Haifa, Israel, 31048
        • Investigational Site Number : 3760005
      • Jerusalem, Israel, 91120
        • Investigational Site Number : 3760002
      • Ramat Gan, Israel, 5266202
        • Investigational Site Number : 3760004
      • Rehovot, Israel, 76100
        • Investigational Site Number : 3760003
  • Italy
      • Bari, Italy, 70124
        • Investigational Site Number : 3800012
      • Brescia, Italy, 25123
        • Investigational Site Number : 3800007
      • Cagliari, Italy, 09124
        • Investigational Site Number : 3800013
      • Genova, Italy, 16132
        • Investigational Site Number : 3800008
      • L'Aquila, Italy, 67100
        • Investigational Site Number : 3800015
      • Milano, Italy, 20122
        • Investigational Site Number : 3800004
      • Napoli, Italy, 80131
        • Investigational Site Number : 3800001
      • Palermo, Italy, 90127
        • Investigational Site Number : 3800018
      • Pisa, Italy, 56126
        • Investigational Site Number : 3800010
      • Roma, Italy, 00137
        • Investigational Site Number : 3800005
      • Torino, Italy, 10126
        • Investigational Site Number : 3800016
    • Ancona
      • Torrette Di Ancona, Ancona, Italy, 60126
        • Investigational Site Number : 3800009
    • Latina
      • Terracina, Latina, Italy, 04019
        • Investigational Site Number : 3800017
    • Roma
      • Rome, Roma, Italy, 00133
        • Investigational Site Number : 3800003
      • Rome, Roma, Italy, 00161
        • Investigational Site Number : 3800011
  • Japan
      • Amagasaki-shi, Japan, 660-8550
        • Investigational Site Number : 3920022
      • Habikino-shi, Japan, 583-8588
        • Investigational Site Number : 3920002
      • Hamamatsu-shi, Japan, 430-0929
        • Investigational Site Number : 3920014
      • Kyoto-shi, Japan, 604-8845
        • Investigational Site Number : 3920025
      • Marugame-shi, Japan, 763-0074
        • Investigational Site Number : 3920013
      • Minokamo-shi, Japan, 505-8503
        • Investigational Site Number : 3920012
      • Nagoya-shi, Japan, 454-8509
        • Investigational Site Number : 3920001
      • Setagaya-ku, Japan, 156-0043
        • Investigational Site Number : 3920010
      • Yokohama-shi, Japan, 234-8503
        • Investigational Site Number : 3920020
    • Aichi
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Investigational Site Number : 3920004
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Investigational Site Number : 3920015
      • Sapporo-shi, Hokkaido, Japan, 060-0807
        • Investigational Site Number : 3920006
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Investigational Site Number : 3920011
    • Saitama
      • Koshigaya-shi, Saitama, Japan, 343-8555
        • Investigational Site Number : 3920008
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Investigational Site Number : 3920005
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Investigational Site Number : 3920003
  • Kuwait
      • Sulaibikat, Kuwait, 90806
        • Investigational Site Number : 4140001
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Investigational Site Number : 4840001
  • Netherlands
      • Bergen op Zoom, Netherlands, 4624 VT
        • Investigational Site Number : 5280002
  • Norway
      • Bergen, Norway, N-5021
        • Investigational Site Number : 5780002
      • Bodø, Norway, 8005
        • Investigational Site Number : 5780001
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Investigational Site Number : 6200003
      • Lisboa, Portugal, 1169-050
        • Investigational Site Number : 6200002
      • Porto, Portugal, 4099-001
        • Investigational Site Number : 6200004
      • Vila Nova de Gaia, Portugal, 4434-502
        • Investigational Site Number : 6200001
  • Russian Federation
      • Moscow, Russian Federation, 123182
        • Investigational Site Number : 6430001
      • Moscow, Russian Federation, 129110
        • Investigational Site Number : 6430002
      • Saint-Petersburg, Russian Federation, 191015
        • Investigational Site Number : 6430004
  • Saudi Arabia
      • Dammam, Saudi Arabia, 31444
        • Investigational Site Number : 6820013
      • Jeddah, Saudi Arabia, 21423
        • Investigational Site Number : 6820001
  • Spain
      • Baracaldo, Spain, 48903
        • Investigational Site Number : 7240017
      • Barcelona, Spain, 08041
        • Investigational Site Number : 7240009
      • Barcelona, Spain
        • Investigational Site Number : 7240014
      • Granada, Spain, 18012
        • Investigational Site Number : 7240021
      • Madrid, Spain, 28034
        • Investigational Site Number : 7240006
      • Madrid, Spain, 28041
        • Investigational Site Number : 7240001
      • Madrid, Spain, 28006
        • Investigational Site Number : 7240016
      • Madrid, Spain, 28031
        • Investigational Site Number : 7240007
      • Madrid, Spain, 28040
        • Investigational Site Number : 7240010
      • Santiago de Compostela, Spain, 15706
        • Investigational Site Number : 7240008
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Investigational Site Number : 7240002
      • Santullano De Mieres, Asturias, Spain, 33611
        • Investigational Site Number : 7240011
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Investigational Site Number : 7240019
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Investigational Site Number : 7240004
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Investigational Site Number : 7240012
  • Taiwan
      • Kaohsiung, Taiwan, 833401
        • Investigational Site Number : 1580012
      • Taichung, Taiwan, 40201
        • Investigational Site Number : 1580011
      • Taipei, Taiwan, 100
        • Investigational Site Number : 1580014
      • Taoyuan County, Taiwan, 333
        • Investigational Site Number : 1580015
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 34761
        • Investigational Site Number : 7840002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population is adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with Dupixent® for AD according to the country-specific prescribing information.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with AD
Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician
Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other Names:
  • Dupixent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline Characteristics: Medical history
Time Frame: Baseline to Month 60
Baseline to Month 60
Baseline Characteristics: Socio-demographics
Time Frame: Baseline to Month 60
Baseline to Month 60
Baseline Characteristics: Disease characteristics
Time Frame: Baseline to Month 60
Baseline to Month 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Time Frame: Baseline to Month 60
Percentage of BSA affected by AD assessed for each major section of the body
Baseline to Month 60
Physician Assessment: Eczema Area and Severity Index (EASI)
Time Frame: Baseline to Month 60
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Baseline to Month 60
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Time Frame: Baseline to Month 60
Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Baseline to Month 60
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Time Frame: Baseline to Month 60
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Baseline to Month 60
Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Time Frame: Baseline to Month 60
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Baseline to Month 60
Participant Assessment: Skin Pain or Soreness NRS
Time Frame: Baseline to Month 60
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Baseline to Month 60
Participant Assessment: Skin Feeling Hot NRS
Time Frame: Baseline to Month 60
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Baseline to Month 60
Participant Assessment: Skin Sensitivity NRS
Time Frame: Baseline to Month 60
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Baseline to Month 60
Participant Assessment: Sleep Disturbance NRS
Time Frame: Baseline to Month 60
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Baseline to Month 60
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
Time Frame: Baseline to Month 60
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Baseline to Month 60
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Time Frame: Baseline to Month 60
Questionnaire to evaluate asthma control in participants with comorbid asthma
Baseline to Month 60
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Time Frame: Baseline to Month 60
Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
Baseline to Month 60
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents
Time Frame: Baseline to Month 60
Questionnaire to assess the impact of AD on productivity
Baseline to Month 60
Participant Assessment: Health Care Resource Utilization Questionnaire
Time Frame: Baseline to Month 60
Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Baseline to Month 60
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Baseline to Month 60
Instrument to measure treatment satisfaction
Baseline to Month 60
Adverse events (AEs)
Time Frame: Baseline to Month 60
Number of participants with at least 1 AE
Baseline to Month 60
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Time Frame: Baseline to Month 60
Questionnaire related with Atopic dermatitis control
Baseline to Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS15990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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