Dermatitis AtopicGLOBOSTADNCT03992417
Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)
An observational study of Dermatitis Atopic, run by Sanofi at 105 sites in 22 countries.
Trial 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®… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- Dupilumab SAR231893 (REGN668)
- Type of treatment
- Injection or infusion
- How many people
- 955 participants
- Where
- 105 sitesin 22 countries
- Study dates
- 11 Jun 2019to 31 Mar 2027
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
105 sites in 22 countries.
105 sites in 22 countries
Japan16 sites
Investigational Site Number : 3920022
Amagasaki-shi, 660-8550
Investigational Site Number : 3920002
Habikino-shi, 583-8588
Investigational Site Number : 3920014
Hamamatsu, 430-0929
Investigational Site Number : 3920011
Hirakata-shi, Osaka, 573-1191
Investigational Site Number : 3920003
Itabashi-ku, Tokyo, 173-8606
Investigational Site Number : 3920008
Koshigaya-shi, Saitama, 343-8555
Investigational Site Number : 3920025
Kyoto, 604-8845
Investigational Site Number : 3920013
Marugame-shi, 763-0074
Investigational Site Number : 3920012
Minokamo-shi, 505-8503
Investigational Site Number : 3920004
Nagakute-shi, Aichi-ken, 480-1195
Investigational Site Number : 3920001
Nagoya, 454-8509
Investigational Site Number : 3920015
Obihiro-shi, Hokkaido, 080-0013
Investigational Site Number : 3920006
Sapporo, Hokkaido, 060-0807
Investigational Site Number : 3920010
Setagaya-ku, 156-0043
Investigational Site Number : 3920005
Shimotsuga-gun, Tochigi, 321-0293
Investigational Site Number : 3920020
Yokohama, 234-8503
Italy14 sites
Investigational Site Number : 3800012
Bari, 70124
Investigational Site Number : 3800007
Brescia, 25123
Investigational Site Number : 3800013
Cagliari, 09124
Investigational Site Number : 3800008
Genova, 16132
Investigational Site Number : 3800015
L’Aquila, 67100
Investigational Site Number : 3800004
Milan, 20122
Investigational Site Number : 3800001
Naples, 80131
Investigational Site Number : 3800010
Pisa, 56126
Investigational Site Number : 3800005
Roma, 00137
Investigational Site Number : 3800003
Rome, Roma, 00133
Investigational Site Number : 3800011
Rome, Roma, 00161
Investigational Site Number : 3800017
Terracina, Latina, 04019
Investigational Site Number : 3800016
Torino, 10126
Investigational Site Number : 3800009
Torrette Di Ancona, Ancona, 60126
Spain13 sites
Investigational Site Number : 7240017
Barakaldo, 48903
Investigational Site Number : 7240009
Barcelona, 08041
Investigational Site Number : 7240014
Barcelona
Investigational Site Number : 7240019
Bilbao, Bizkaia, 48013
Investigational Site Number : 7240004
Las Palmas de Gran Canaria, Las Palmas, 35010
Investigational Site Number : 7240016
Madrid, 28006
Investigational Site Number : 7240007
Madrid, 28031
Investigational Site Number : 7240006
Madrid, 28034
Investigational Site Number : 7240010
Madrid, 28040
Investigational Site Number : 7240001
Madrid, 28041
Investigational Site Number : 7240012
Majadahonda, Madrid, 28222
Investigational Site Number : 7240002
Oviedo, Principality of Asturias, 33011
Investigational Site Number : 7240008
Santiago de Compostela, 15706
France8 sites
Investigational Site Number : 2500011
Antony, 92160
Investigational Site Number : 2500003
Bordeaux, 33000
Investigational Site Number : 2500009
Montpellier, 34295
Investigational Site Number : 2500006
Pierre-Bénite, 69495
Investigational Site Number : 2500010
Rouen, 76000
Investigational Site Number : 2500005
Saint-Mandé Cedex, 94160
Investigational Site Number : 2500002
Toulouse, 31059
Investigational Site Number : 2500001
Valence, 26953
Belgium7 sites
Investigational Site Number : 0560002
Brussels, 1200
Investigational Site Number : 0560007
Edegem, 2650
Investigational Site Number : 0560010
Ghent, 9000
Investigational Site Number : 0560003
Jette, 1090
Investigational Site Number : 0560001
Leige, 4000
Investigational Site Number : 0560008
Leuven, 3000
Investigational Site Number : 0560006
Roeselare, 8800
Czechia7 sites
Investigational Site Number : 2030008
Hradec Králové, 50005
Investigational Site Number : 2030006
Olomouc, 77900
Investigational Site Number : 2030003
Ostrava - Poruba, 70852
Investigational Site Number : 2030004
Pilsen, 304 60
Investigational Site Number : 2030005
Prague, 110 01
Investigational Site Number : 2030002
Prague, 150 06
Investigational Site Number : 2030001
Ústí nad Labem, 40113
Australia5 sites
Investigational Site Number : 0360004
Bedford Park, South Australia, 5042
Investigational Site Number : 0360001
Carlton, Victoria, 3053
Investigational Site Number : 0360002
Kogarah, New South Wales, 2217
Investigational Site Number : 0360005
Kogarah, New South Wales, 2217
Investigational Site Number : 0360003
Woolloongabba, Queensland, 4102
Israel5 sites
Investigational Site Number : 3760006
Afula, 18101
Investigational Site Number : 3760005
Haifa, 31048
Investigational Site Number : 3760001
Haifa, 3109601
Investigational Site Number : 3760002
Jerusalem, 91120
Investigational Site Number : 3760004
Ramat Gan, 5266202
Austria4 sites
Investigational Site Number : 0400005
Graz, 8036
Investigational Site Number : 0400004
Linz, 4020
Investigational Site Number : 0400002
Maria Enzersdorf, 2344
Investigational Site Number : 0400001
Vienna, 1220
Portugal4 sites
Investigational Site Number : 6200003
Coimbra, 3000-075
Investigational Site Number : 6200002
Lisbon, 1169-050
Investigational Site Number : 6200004
Porto, 4099-001
Investigational Site Number : 6200001
Vila Nova de Gaia, 4434-502
Taiwan4 sites
Investigational Site Number : 1580012
Kaohsiung City, 833401
Investigational Site Number : 1580011
Taichung, 40201
Investigational Site Number : 1580014
Taipei, 100
Investigational Site Number : 1580015
Taoyuan County, 333
Argentina3 sites
Investigational Site Number : 0320011
Ciudad Autonoma Bs As, C1121ABE
Investigational Site Number : 0320013
Pilar, Buenos Aires, B1629ODT
Investigational Site Number : 0320012
Rosario, Santa Fe Province, S2000DBS
Colombia3 sites
Investigational Site Number : 1700008
Bogotá, 11001
Investigational Site Number : 1700012
Bogotá, 110221
Investigational Site Number : 1700011
Medellín, 050034
Greece2 sites
Investigational Site Number : 3000003
Thessaloniki, 54645
Investigational Site Number : 3000001
Thessaloniki, 56403
Norway2 sites
Investigational Site Number : 5780002
Bergen, N-5021
Investigational Site Number : 5780001
Bodø, 8005
Russia2 sites
Investigational Site Number : 6430001
Moscow, 123182
Investigational Site Number : 6430004
Saint Petersburg, 191015
Netherlands1 site
Investigational Site Number : 5280002
Bergen op Zoom, 4624 VT
United Arab Emirates1 site
Investigational Site Number : 7840002
Abu Dhabi, 34761
About this study
Official title: 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
Read more
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
Read the detailed description
Participants enrolled in the study will be followed for 5 years.
- Conditions
- Dermatitis Atopic
- Being tested
- Dupilumab SAR231893 (REGN668)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab SAR231893 (REGN668)Drug
Also called Dupixent®
Pharmaceutical form: solution for injection
Route of administration: subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dupilumab SAR231893 (REGN668) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Characteristics: Medical history
Measured: Baseline to Month 60
Baseline Characteristics: Socio-demographics
Measured: Baseline to Month 60
Baseline Characteristics: Disease characteristics
Measured: Baseline to Month 60
Secondary outcomes (17)
Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Percentage of BSA affected by AD assessed for each major section of the body
Measured: Baseline to Month 60
Physician Assessment: Eczema Area and Severity Index (EASI)
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Measured: Baseline to Month 60
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Measured: Baseline to Month 60
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Measured: Baseline to Month 60
Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Measured: Baseline to Month 60
Participant Assessment: Skin Pain or Soreness NRS
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Measured: Baseline to Month 60
Participant Assessment: Skin Feeling Hot NRS
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Measured: Baseline to Month 60
Participant Assessment: Skin Sensitivity NRS
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Measured: Baseline to Month 60
Participant Assessment: Sleep Disturbance NRS
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Measured: Baseline to Month 60
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Measured: Baseline to Month 60
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Questionnaire to evaluate asthma control in participants with comorbid asthma
Measured: Baseline to Month 60
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
Measured: 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
Questionnaire to assess the impact of AD on productivity
Measured: Baseline to Month 60
Participant Assessment: Health Care Resource Utilization Questionnaire
Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Measured: Baseline to Month 60
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Instrument to measure treatment satisfaction
Measured: Baseline to Month 60
Adverse events (AEs)
Number of participants with at least 1 AE
Measured: Baseline to Month 60
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Questionnaire related with Atopic dermatitis control
Measured: Baseline to Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start11 Jun 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis AtopicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 955 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992417
- Sponsor's protocol ID
- OBS15990
- Acronym
- GLOBOSTAD
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39621227Calzavara-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.
PubMed 37801232
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03992417
- Acronym / sponsor ID
- GLOBOSTAD / OBS15990
- Conditions
- Dermatitis Atopic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 955 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Participants enrolled in the study will be followed for 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with AD | – | Drug: Dupilumab SAR231893 (REGN668)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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumab SAR231893 (REGN668)Also: Dupixent®Pharmaceutical form: solution for injection Route of administration: subcutaneous injection | Drug | Participants with AD |
Primary outcome
Baseline Characteristics: Medical history
Time frame: Baseline to Month 60
Baseline Characteristics: Socio-demographics
Time frame: Baseline to Month 60
Baseline Characteristics: Disease characteristics
Time frame: Baseline to Month 60
17 secondary outcomes
Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Time frame: Baseline to Month 60
Physician Assessment: Eczema Area and Severity Index (EASI)
Time frame: Baseline to Month 60
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Time frame: Baseline to Month 60
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Time frame: Baseline to Month 60
Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline to Month 60
Participant Assessment: Skin Pain or Soreness NRS
Time frame: Baseline to Month 60
Participant Assessment: Skin Feeling Hot NRS
Time frame: Baseline to Month 60
Participant Assessment: Skin Sensitivity NRS
Time frame: Baseline to Month 60
Participant Assessment: Sleep Disturbance NRS
Time frame: 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
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Time frame: Baseline to Month 60
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Time frame: 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
Participant Assessment: Health Care Resource Utilization Questionnaire
Time frame: Baseline to Month 60
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: Baseline to Month 60
Adverse events (AEs)
Time frame: Baseline to Month 60
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Time frame: Baseline to Month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 39621227Calzavara-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.
- Derived from this study: PubMed 37801232Calzavara-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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
105 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis Atopic, run by Sanofi at 105 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in Japan, Italy, Spain, France, Belgium and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Characteristics: Medical history (time frame: Baseline to Month 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.