Status:
ACTIVE_NOT_RECRUITING
Registry of Asthma Patients Initiating DUPIXENT®
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Brief Summary
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real lif...
Detailed Description
3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over
Eligibility Criteria
Inclusion
- Key
- Willing and able to comply with the required clinic visits, study procedures and assessments
- Able to understand and complete study-related questionnaires
- Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
- Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
- Key
Exclusion
- Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
- Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
- Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 13 2026
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT04287621
Start Date
March 2 2020
End Date
May 13 2026
Last Update
April 22 2025
Active Locations (128)
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1
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35209
2
Arizona Allergy & Immunology Research
Gilbert, Arizona, United States, 85234
3
Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.
Scottsdale, Arizona, United States, 85251
4
Children's Hospital of Orange County
Orange, California, United States, 92868