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

Dermatitis, Atopic Clinical Trial

— PROSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03428646
• Other study ID #: R668-AD-1762
• Status: Active, not recruiting
• Start date: April 6, 2018
• Est. completion date: March 30, 2027

Study information

• Verified date: September 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 858
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Dupilumab
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.

Locations

Country	Name	City	State
Canada	Regeneron Investigational Site	Hamilton	Ontario
Canada	Regeneron Investigational Site	Markham	Ontario
Canada	Regeneron Investigational Site	Ottawa	Ontario
Canada	Regeneron Investigational Site	Peterborough	Ontario
Canada	Regeneron Investigational Site	Quebec
Canada	Regeneron Investigational Site	Toronto	Ontario
United States	Regeneron Investigational Site	Akron	Ohio
United States	Regeneron Investigational Site	Ann Arbor	Michigan
United States	Regeneron Investigational Site	Arlington	Virginia
United States	Regeneron Investigational Site	Athens	Ohio
United States	Regeneron Investigational Site	Atlanta	Georgia
United States	Regeneron Investigational Site	Bay City	Michigan
United States	Regeneron Investigational Site	Bellaire	Texas
United States	Regeneron Investigational Site	Bellevue	Washington
United States	Regeneron Investigational Site	Bexley	Ohio
United States	Regeneron Investigational Site	Birmingham	Alabama
United States	Regeneron Investigational Site	Blue Bell	Pennsylvania
United States	Regeneron Investigational Site	Brick	New Jersey
United States	Regeneron Investigational Site	Bronx	New York
United States	Regeneron Investigational Site	Champaign	Illinois
United States	Regeneron Investigational Site	Charleston	South Carolina
United States	Regeneron Investigational Site	Chicago	Illinois
United States	Regeneron Investigational Site	Columbia	Missouri
United States	Regeneron Investigational Site	Concord	North Carolina
United States	Regeneron Investigational Site	Coral Gables	Florida
United States	Regeneron Investigational Site	Corbin	Kentucky
United States	Regeneron Investigational Site	Dallas	Texas
United States	Regeneron Investigational Site	East Windsor	New Jersey
United States	Regeneron Investigational Site	Edison	New Jersey
United States	Regeneron Investigational Site	Elmhurst	New York
United States	Regeneron Investigational Site	Forest Hills	New York
United States	Regeneron Investigational Site	Fort Wayne	Indiana
United States	Regeneron Investigational Site	Fountain Valley	California
United States	Regeneron Investigational Site	Garden City	New York
United States	Regeneron Investigational Site	Gilbert	Arizona
United States	Regeneron Investigational Site	Grapevine	Texas
United States	Regeneron Investigational Site	Henderson	Nevada
United States	Regeneron Investigational Site	Kew Gardens	New York
United States	Regeneron Investigational Site	Kirksville	Missouri
United States	Regeneron Investigational Site	La Grange Park	Illinois
United States	Regeneron Investigational Site	Laguna Hills	California
United States	Regeneron Investigational Site	Lake Success	New York
United States	Regeneron Investigational Site	Las Vegas	Nevada
United States	Regeneron Investigational Site	Lincoln	Nebraska
United States	Regeneron Investigational Site	Loma Linda	California
United States	Regeneron Investigational Site	Los Angeles	California
United States	Regeneron Investigational Site	Los Angeles	California
United States	Regeneron Investigational Site	Louisville	Kentucky
United States	Regeneron Investigational Site	Macon	Georgia
United States	Regeneron Investigational Site	Manhasset	New York
United States	Regeneron Investigational Site	Manhattan Beach	California
United States	Regeneron Investigational Site	Margate	Florida
United States	Regeneron Investigational Site	Marietta	Georgia
United States	Regeneron Investigational Site	Marietta	Georgia
United States	Regeneron Investigational Site	Marion	Ohio
United States	Regeneron Investigational Site	Mason	Ohio
United States	Regeneron Investigational Site	Milwaukee	Wisconsin
United States	Regeneron Investigational Site	Mineola	New York
United States	Regeneron Investigational Site	Mount Vernon	New York
United States	Regeneron Investigational Site	New Haven	Connecticut
United States	Regeneron Investigational Site	New York	New York
United States	Regeneron Investigational Site	New York	New York
United States	Regeneron Investigational Site	New York	New York
United States	Regeneron Investigational Site	New York	New York
United States	Regeneron Investigational Site	Newport Beach	California
United States	Regeneron Investigational Site	Norfolk	Virginia
United States	Regeneron Investigational Site	North Charleston	South Carolina
United States	Regeneron Investigational Site	Oceanside	California
United States	Regeneron Investigational Site	Overland Park	Kansas
United States	Regeneron Investigational Site	Philadelphia	Pennsylvania
United States	Regeneron Investigational Site	Philadelphia	Pennsylvania
United States	Regeneron Investigational Site	Piscataway	New Jersey
United States	Regeneron Investigational Site	Plainfield	Indiana
United States	Regeneron Investigational Site	Portland	Oregon
United States	Regeneron Investigational Site	Quincy	Massachusetts
United States	Regeneron Investigational Site	Redondo Beach	California
United States	Regeneron Investigational Site	Riverside	California
United States	Regeneron Investigational Site	Rockville	Maryland
United States	Regeneron Investigational Site	Roseville	California
United States	Regeneron Investigational Site	Saint Louis	Missouri
United States	Regeneron Investigational Site	San Antonio	Texas
United States	Regeneron Investigational Site	San Diego	California
United States	Regeneron Investigational Site	Sandy Springs	Georgia
United States	Regeneron Investigational Site	Santa Monica	California
United States	Regeneron Investigational Site	Sellersville	Pennsylvania
United States	Regeneron Investigational Site	Skokie	Illinois
United States	Regeneron Investigational Site	Springfield	Illinois
United States	Regeneron Investigational Site	Sugar Land	Texas
United States	Regeneron Investigational Site	Sugar Land	Texas
United States	Regeneron Investigational Site	Thousand Oaks	California
United States	Regeneron Investigational Site	Towson	Maryland
United States	Regeneron Investigational Site	Troy	Michigan
United States	Regeneron Investigational Site	Troy	New York
United States	Regeneron Investigational Site	Tulsa	Oklahoma
United States	Regeneron Investigational Site	Upper Marlboro	Maryland
United States	Regeneron Investigational Site	Warren	Michigan
United States	Regeneron Investigational Site	West Palm Beach	Florida
United States	Regeneron Investigational Site	White Marsh	Maryland
United States	Regeneron Investigational Site	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registry Assessment: Baseline Characteristics	Medical history	At baseline (day when DUPIXENT treatment is initiated)
Primary	Registry Assessment: Baseline Characteristic	Socio-demographics	At baseline (day when DUPIXENT treatment is initiated)
Secondary	Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis	Percentage of BSA affected by AD assessed for each major section of the body	Baseline to month 60
Secondary	Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)	Measure used in clinical practice and clinical trials to assess the severity and extent of AD	Baseline to month 60
Secondary	Registry (Physician) Assessment: Overall Disease Severity scale	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)	Baseline to month 60
Secondary	Registry (Participant) Assessment: Patient Oriented Eczema Measure	Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults	Baseline to month 60
Secondary	Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)	Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Skin Pain or Soreness NRS	Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS	Baseline to month 60
Secondary	Registry (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	Baseline to month 60
Secondary	Registry (Participant) Assessment: Skin Sensitivity NRS	Individual NRS used to rate skin sensitivity using a 0 to 10 NRS	Baseline to month 60
Secondary	Registry (Participant) Assessment: Sleep Disturbance NRS	Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS	Baseline to month 60
Secondary	Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale	Rate of overall well-being on a 5-point scale.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)	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	Baseline to month 60
Secondary	Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)	Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)	Questionnaire to assess the impact of AD on productivity.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire	Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire	Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Missed School Days	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.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)	5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)	Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.	Baseline to month 60
Secondary	Registry (Participant) Assessment: Changes in Concurrent Conditions	Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).	Baseline to month 60
Secondary	Registry (Participant) Assessment: Overall Health State	Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).	Baseline to month 60