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NCT Number: NCT03992417

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 0320013, Pilar, Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab SAR231893 (REGN668)

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other names: Dupixent®

Primary outcomes

  1. Baseline Characteristics: Medical history

    Time frame: Baseline to Month 60

  2. Baseline Characteristics: Socio-demographics

    Time frame: Baseline to Month 60

  3. Baseline Characteristics: Disease characteristics

    Time frame: Baseline to Month 60

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Participant Assessment: Skin Sensitivity NRS

    Time frame: Baseline to Month 60

    Individual NRS used to rate skin sensitivity using a 0 to 10 NRS

  9. 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

  10. 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)

  11. Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)

    Time frame: Baseline to Month 60

    Questionnaire to evaluate asthma control in participants with comorbid asthma

  12. 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

  13. 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

  14. 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

  15. Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    Time frame: Baseline to Month 60

    Instrument to measure treatment satisfaction

  16. Adverse events (AEs)

    Time frame: Baseline to Month 60

    Number of participants with at least 1 AE

  17. Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally

    Time frame: Baseline to Month 60

    Questionnaire related with Atopic dermatitis control

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: GLOBOSTAD

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2019
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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