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NCT Number: NCT03428646

Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

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 Eczema 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

Regeneron Investigational Site, Hamilton, Ontario, Canada

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About this study

This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® 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; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
  • Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
  • Willing and able to comply with study-related activities.
  • Able to understand and complete study-related questionnaires.
  • Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.

Key Exclusion Criteria:

  • Patients 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 patient from adequately completing the schedule of visits and assessments.
  • Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Dupilumab

Drug

Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.

Other names: DUPIXENT®, REGN668

Primary outcomes

  1. Registry Assessment: Baseline Characteristics

    Time frame: At baseline (day when DUPIXENT treatment is initiated)

    Medical history

  2. Registry Assessment: Baseline Characteristic

    Time frame: At baseline (day when DUPIXENT treatment is initiated)

    Socio-demographics

Secondary outcomes

  1. Registry (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. Registry (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. Registry (Physician) Assessment: Overall Disease Severity scale

    Time frame: Baseline to month 60

    Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease)

  4. Registry (Participant) Assessment: Patient Oriented Eczema Measure

    Time frame: Baseline to month 60

    Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults

  5. Registry (Participant) Assessment: Pruritus Numerical Rating Scales (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. Registry (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. Registry (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. Registry (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. Registry (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. Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale

    Time frame: Baseline to month 60

    Rate of overall well-being on a 5-point scale.

  11. Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)

    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) in adults

  12. Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)

    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 QOL in pediatrics.

  13. Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)

    Time frame: Baseline to month 60

    Questionnaire to assess the impact of AD on productivity.

  14. Registry (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. Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire

    Time frame: Baseline to month 60

    Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.

  16. Registry (Participant) Assessment: Missed School Days

    Time frame: Baseline to month 60

    Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to < 18 years) who are enrolled in school.

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

    Time frame: Baseline to month 60

    5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.

  18. Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)

    Time frame: Baseline to month 60

    Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.

  19. Registry (Participant) Assessment: Changes in Concurrent Conditions

    Time frame: Baseline to month 60

    Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).

  20. Registry (Participant) Assessment: Overall Health State

    Time frame: Baseline to month 60

    Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: PROSE

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2018
Registry last updated
Dec 29, 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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