Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)
- Sponsor
- Sanofi
- Study ID
- NCT03992417
- Status
- Active Not Recruiting
Conditions
- Dermatitis Atopic
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab SAR231893 (REGN668) — DRUGPharmaceutical form: solution for injection Route of administration: subcutaneous injection
Study Details
Primary Objective: To characterize the patients who receive Dupixent® (dupilumab) 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 Secondary Objectives: * To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) * To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting * To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD * To collect safety data on study participants
Key Dates
- Start date
- Jun 11, 2019
- Status verified
- Jul 2025
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 955 participants (actual)
Arms
- Arm: Participants with ADAdult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician
Primary Outcome Measure
Baseline Characteristics: Medical history [ Time Frame: Baseline to Month 60 ]
Related Studies
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- A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK InhibitorPHASE3 · Recruiting · Sanofi · Birmingham, Alabama