Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Regeneron Pharmaceuticals

Status: Active, not recruiting

Conditions: Asthma

Treatments: Drug: DUPIXENT®

Study type: Observational

Funder types: Industry

Identifiers

NCT04287621

EUPAS41963 (Other Identifier)

R668-AS-1885

Details and patient eligibility

About

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 life.

This includes characterization of:

• Patient demographics (eg, gender, age, and race)
• Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

• To characterize real-world use patterns of DUPIXENT® for asthma
• To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
• To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
• To collect long-term safety data on study participants in the real-world setting

Full description

3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Enrollment: 718 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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.