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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428646
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment
Dermatitis, Atopic Drug: 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab


Intervention Details:
  • 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.
    Other Names:
    • DUPIXENT®
    • REGN668


Primary Outcome Measures :
  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 Outcome Measures :
  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).


Biospecimen Retention:   Samples With DNA
Optional sub-study: Blood samples will be collected and stored up to 10 years for future use in bio-marker research. Participants who agree to provide blood samples for future research will be required to sign a separate informed consent form (ICF) before collection of the samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population comprises 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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428646


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Medical Affairs Regeneron Pharmaceuticals

Additional Information:

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03428646    
Other Study ID Numbers: R668-AD-1762
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs