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

NCT03992417 | Active Not Recruiting

• 1 other identifier: OBS15990
• Study Type: observational
• Target: 955
• Locations: 21 countries
• Sites: 109

Brief 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

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (3)

• Baseline Characteristics: Medical history

  Baseline to Month 60

• Baseline Characteristics: Socio-demographics

  Baseline to Month 60

• Baseline Characteristics: Disease characteristics

  Baseline to Month 60

Secondary Outcomes (17)

• Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis

  Baseline to Month 60

• Physician Assessment: Eczema Area and Severity Index (EASI)

  Baseline to Month 60

• Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)

  Baseline to Month 60

• Participant Assessment: Patient Oriented Eczema Measure (POEM)

  Baseline to Month 60

• Participant Assessment: Pruritus Numerical Rating Scale (NRS)

  Baseline to Month 60

Study Arms (1)

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)

Interventions

Dupilumab SAR231893 (REGN668) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Also known as: Dupixent®

Participants with AD

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (114)

Investigational Site Number : 0320013

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Investigational Site Number : 0320012

Rosario, Santa Fe Province, S2000DBS, Argentina

Location

Investigational Site Number : 0320011

Ciudad Autonoma Bs As, C1121ABE, Argentina

Location

Investigational Site Number : 0360002

Kogarah, New South Wales, 2217, Australia

Location

Investigational Site Number : 0360005

Kogarah, New South Wales, 2217, Australia

Location

Investigational Site Number : 0360003

Woolloongabba, Queensland, 4102, Australia

Location

Investigational Site Number : 0360004

Bedford Park, South Australia, 5042, Australia

Location

Investigational Site Number : 0360001

Carlton, Victoria, 3053, Australia

Location

Investigational Site Number : 0400005

Graz, 8036, Austria

Location

Investigational Site Number : 0400004

Linz, 4020, Austria

Location

Investigational Site Number : 0400002

Maria Enzersdorf, 2344, Austria

Location

Investigational Site Number : 0400001

Vienna, 1220, Austria

Location

Investigational Site Number : 0560002

Brussels, 1200, Belgium

Location

Investigational Site Number : 0560007

Edegem, 2650, Belgium

Location

Investigational Site Number : 0560010

Ghent, 9000, Belgium

Location

Investigational Site Number : 0560003

Jette, 1090, Belgium

Location

Investigational Site Number : 0560001

Leige, 4000, Belgium

Location

Investigational Site Number : 0560008

Leuven, 3000, Belgium

Location

Investigational Site Number : 0560004

Namur, 5000, Belgium

Location

Investigational Site Number : 0560006

Roeselare, 8800, Belgium

Location

Investigational Site Number : 1700008

Bogotá, 11001, Colombia

Location

Investigational Site Number : 1700012

Bogotá, 110221, Colombia

Location

Investigational Site Number : 1700011

Medellín, 050034, Colombia

Location

Investigational Site Number : 2030008

Hradec Králové, 50005, Czechia

Location

Investigational Site Number : 2030006

Olomouc, 77900, Czechia

Location

Investigational Site Number : 2030003

Ostrava - Poruba, 70852, Czechia

Location

Investigational Site Number : 2030004

Pilsen, 304 60, Czechia

Location

Investigational Site Number : 2030005

Prague, 110 01, Czechia

Location

Investigational Site Number : 2030002

Prague, 150 06, Czechia

Location

Investigational Site Number : 2030001

Ústí nad Labem, 40113, Czechia

Location

Investigational Site Number : 2460002

Kokkola, 67200, Finland

Location

Investigational Site Number : 2500011

Antony, 92160, France

Location

Investigational Site Number : 2500004

Auxerre, 89000, France

Location

Investigational Site Number : 2500003

Bordeaux, 33000, France

Location

Investigational Site Number : 2500009

Montpellier, 34295, France

Location

Investigational Site Number : 2500006

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500010

Rouen, 76000, France

Location

Investigational Site Number : 2500005

Saint-Mandé Cedex, 94160, France

Location

Investigational Site Number : 2500002

Toulouse, 31059, France

Location

Investigational Site Number : 2500001

Valence, 26953, France

Location

Investigational Site Number : 3000002

Athens, 16121, Greece

Location

Investigational Site Number : 3000003

Thessaloniki, 54645, Greece

Location

Investigational Site Number : 3000001

Thessaloniki, 56403, Greece

Location

Investigational Site Number : 3760006

Afula, 18101, Israel

Location

Investigational Site Number : 3760005

Haifa, 31048, Israel

Location

Investigational Site Number : 3760001

Haifa, 3109601, Israel

Location

Investigational Site Number : 3760002

Jerusalem, 91120, Israel

Location

Investigational Site Number : 3760004

Ramat Gan, 5266202, Israel

Location

Investigational Site Number : 3760003

Rehovot, 76100, Israel

Location

Investigational Site Number : 3800009

Torrette Di Ancona, Ancona, 60126, Italy

Location

Investigational Site Number : 3800017

Terracina, Latina, 04019, Italy

Location

Investigational Site Number : 3800003

Rome, Roma, 00133, Italy

Location

Investigational Site Number : 3800011

Rome, Roma, 00161, Italy

Location

Investigational Site Number : 3800012

Bari, 70124, Italy

Location

Investigational Site Number : 3800007

Brescia, 25123, Italy

Location

Investigational Site Number : 3800013

Cagliari, 09124, Italy

Location

Investigational Site Number : 3800008

Genova, 16132, Italy

Location

Investigational Site Number : 3800015

L’Aquila, 67100, Italy

Location

Investigational Site Number : 3800004

Milan, 20122, Italy

Location

Investigational Site Number : 3800001

Napoli, 80131, Italy

Location

Investigational Site Number : 3800018

Palermo, 90127, Italy

Location

Investigational Site Number : 3800010

Pisa, 56126, Italy

Location

Investigational Site Number : 3800005

Roma, 00137, Italy

Location

Investigational Site Number : 3800016

Torino, 10126, Italy

Location

Investigational Site Number : 3920004

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

Investigational Site Number : 3920015

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Investigational Site Number : 3920006

Sapporo, Hokkaido, 060-0807, Japan

Location

Investigational Site Number : 3920011

Hirakata-shi, Osaka, 573-1191, Japan

Location

Investigational Site Number : 3920008

Koshigaya-shi, Saitama, 343-8555, Japan

Location

Investigational Site Number : 3920005

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Investigational Site Number : 3920003

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Investigational Site Number : 3920022

Amagasaki-shi, 660-8550, Japan

Location

Investigational Site Number : 3920002

Habikino-shi, 583-8588, Japan

Location

Investigational Site Number : 3920014

Hamamatsu, 430-0929, Japan

Location

Investigational Site Number : 3920025

Kyoto, 604-8845, Japan

Location

Investigational Site Number : 3920013

Marugame-shi, 763-0074, Japan

Location

Investigational Site Number : 3920012

Minokamo-shi, 505-8503, Japan

Location

Investigational Site Number : 3920001

Nagoya, 454-8509, Japan

Location

Investigational Site Number : 3920010

Setagaya-ku, 156-0043, Japan

Location

Investigational Site Number : 3920020

Yokohama, 234-8503, Japan

Location

Investigational Site Number : 4140001

Sulaibikat, 90806, Kuwait

Location

Investigational Site Number : 4840001

Guadalajara, Jalisco, 44130, Mexico

Location

Investigational Site Number : 5280002

Bergen op Zoom, 4624 VT, Netherlands

Location

Investigational Site Number : 5780002

Bergen, N-5021, Norway

Location

Investigational Site Number : 5780001

Bodø, 8005, Norway

Location

Investigational Site Number : 6200003

Coimbra, 3000-075, Portugal

Location

Investigational Site Number : 6200002

Lisbon, 1169-050, Portugal

Location

Investigational Site Number : 6200004

Porto, 4099-001, Portugal

Location

Investigational Site Number : 6200001

Vila Nova de Gaia, 4434-502, Portugal

Location

Investigational Site Number : 6430001

Moscow, 123182, Russia

Location

Investigational Site Number : 6430002

Moscow, 129110, Russia

Location

Investigational Site Number : 6430004

Saint Petersburg, 191015, Russia

Location

Investigational Site Number : 6820013

Dammam, 31444, Saudi Arabia

Location

Investigational Site Number : 6820001

Jeddah, 21423, Saudi Arabia

Location

Investigational Site Number : 7240019

Bilbao, Bizkaia, 48013, Spain

Location

Investigational Site Number : 7240004

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Investigational Site Number : 7240012

Majadahonda, Madrid, 28222, Spain

Location

Investigational Site Number : 7240002

Oviedo, Principality of Asturias, 33011, Spain

Location

Investigational Site Number : 7240011

Santullano de Mieres, Principality of Asturias, 33611, Spain

Location

Investigational Site Number : 7240017

Barakaldo, 48903, Spain

Location

Investigational Site Number : 7240009

Barcelona, 08041, Spain

Location

Investigational Site Number : 7240014

Barcelona, Spain

Location

Investigational Site Number : 7240021

Granada, 18012, Spain

Location

Investigational Site Number : 7240016

Madrid, 28006, Spain

Location

Investigational Site Number : 7240007

Madrid, 28031, Spain

Location

Investigational Site Number : 7240006

Madrid, 28034, Spain

Location

Investigational Site Number : 7240010

Madrid, 28040, Spain

Location

Investigational Site Number : 7240001

Madrid, 28041, Spain

Location

Investigational Site Number : 7240008

Santiago de Compostela, 15706, Spain

Location

Investigational Site Number : 1580012

Kaohsiung City, 833401, Taiwan

Location

Investigational Site Number : 1580011

Taichung, 40201, Taiwan

Location

Investigational Site Number : 1580014

Taipei, 100, Taiwan

Location

Investigational Site Number : 1580015

Taoyuan, 333, Taiwan

Location

Investigational Site Number : 7840002

Abu Dhabi, 34761, United Arab Emirates

Location

Related Publications (2)

• Calzavara-Pinton P, Chu CY, Lapeere H, Rossi M, Ferrucci SM, Chung WH, Fougerousse AC, Fomina DS, Holzer G, Celakovska J, Al-Ahmad M, Tzellos T, Wu J, Ardeleanu M, Bosman K. One-Year Insights into the GLOBOSTAD Multinational Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis. Adv Ther. 2025 Feb;42(2):720-733. doi: 10.1007/s12325-024-03049-8. Epub 2024 Dec 2.

  PMID: 39621227 DERIVED

• Calzavara-Pinton P, Celakovska J, Lapeere H, Holzer G, Al-Ahmad M, Chu CY, Ferrucci SM, Kataoka Y, Rossi M, Fomina DS, Chung WH, Tzellos T, Fougerousse AC, Wu J, Ardeleanu M, Ozturk ZE. Baseline Demographics, Comorbidities, Treatment Patterns and Burden of Atopic Dermatitis in Adults and Adolescents from the GLOBOSTAD Long-Term Observational Study. Adv Ther. 2023 Dec;40(12):5366-5382. doi: 10.1007/s12325-023-02644-5. Epub 2023 Oct 6.

  PMID: 37801232 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: June 11, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (8); CZ (7); AE (1); NO (2); SA (2); AU (4); GR (3); CO (3); IL (6); ME (1); ES (15); IT (15); PT (4); AR (3); NL (1); JP (16); FI (1); TW (4); KU (1); RU (3); FR (9)