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

Active, not recruiting

• Conditions: Dermatitis, Atopic

• Registration Number: NCT03428646
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-09
• Study Start: 2018-04-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2027-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 858

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Registry Assessment: Baseline Characteristics	At baseline (day when DUPIXENT treatment is initiated)	Medical history
Registry Assessment: Baseline Characteristic	At baseline (day when DUPIXENT treatment is initiated)	Socio-demographics

Secondary Outcome Measures

Name	Time	Method
Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis	Baseline to month 60	Percentage of BSA affected by AD assessed for each major section of the body
Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)	Baseline to month 60	Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Registry (Physician) Assessment: Overall Disease Severity scale	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)
Registry (Participant) Assessment: Patient Oriented Eczema Measure	Baseline to month 60	Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)	Baseline to month 60	Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.
Registry (Participant) Assessment: Skin Pain or Soreness NRS	Baseline to month 60	Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Registry (Participant) Assessment: Skin Feeling Hot NRS	Baseline to month 60	Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Registry (Participant) Assessment: Skin Sensitivity NRS	Baseline to month 60	Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Registry (Participant) Assessment: Sleep Disturbance NRS	Baseline to month 60	Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale	Baseline to month 60	Rate of overall well-being on a 5-point scale.
Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)	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
Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)	Baseline to month 60	Questionnaire to assess the impact of AD on productivity.
Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)	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.
Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire	Baseline to month 60	Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.
Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire	Baseline to month 60	Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.
Registry (Participant) Assessment: Missed School Days	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.
Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)	Baseline to month 60	5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.
Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)	Baseline to month 60	Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.
Registry (Participant) Assessment: Changes in Concurrent Conditions	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).
Registry (Participant) Assessment: Overall Health State	Baseline to month 60	Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).

Trial Locations

Locations (1)

Regeneron Investigational Site; 🇨🇦 Quebec, Canada