A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Sanofi
Study ID
NCT07316114
Status
Recruiting
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Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Study Details

This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU). This study will be conducted in the United States and will collect data available from participants' medical files, other items routinely collected during disease management in clinical practice, and patient-reported outcomes related to disease, work productivity, quality of life, and CSU-related hospitalizations. Participation in this study is the patient's own choice and is entirely voluntary. The treating physician prescribes dupilumab treatment as part of routine care, independently of the study. Once the decision to prescribe dupilumab is made by the treating physician, patients can self-screen and will be contacted by the Virtual Research Coordination Center to determine potential study eligibility. Patients will be enrolled if they provide an informed consent and meet all inclusion criteria and none of the exclusion criteria. The duration of the study for each participant is 24 months. All patients will be followed for 24 months or until death, loss to follow-up, or withdrawal, whichever occurs first.

Key Dates

Start date
Mar 18, 2026
Status verified
Apr 2026
Primary completion
Nov 24, 2027
Completion
Nov 22, 2029

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

Summary of Sociodemographic Characteristics [ Time Frame: Baseline ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual Research Coordination CenterWilmingtonNorth Carolina28401-3331
Ghazaleh Bahrami
877-316-2285

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By research site
Virtual Research Coordination Center· Wilmington, NC

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