Actively Recruiting
A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria
Led by Sanofi · Updated on 2026-04-14
400
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to understand how dupilumab is used and performs in real-world patients with chronic spontaneous urticaria (CSU). The study focuses on assessing dupilumab's effectiveness, safety, and usage patterns by collecting data from patients' medical records, routine clinical care, and patient-reported outcomes. This study will take place in the United States and aims to provide insights over a 24-month follow-up period. Participants in this study receive dupilumab treatment as prescribed by their own doctors as part of routine medical care, without any treatment administered by the study itself. After the decision to treat with dupilumab is made, patients can self-screen and enroll if eligible. The study does not interfere with treatment decisions but observes how the medication is used and its impact in everyday clinical settings over two years. During the study, participants will be monitored for various aspects including their disease activity, quality of life, work productivity, treatment satisfaction, and any hospitalizations related to CSU. Data will be collected at baseline and throughout up to 24 months. Safety events and medication use patterns will also be recorded. Participants' information is gathered through medical files and questionnaires, with follow-up continuing until the study ends, withdrawal, loss to follow-up, or death.
CONDITIONS
Brief Title
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older at the time of informed consent or assent
- Physician decided to treat the patient with dupilumab for chronic spontaneous urticaria before study participation
- Patient is able to understand and complete study-related questionnaires
- Patients and/or parent or legally authorized representative provide voluntary informed consent or assent before joining the study
You will not qualify if you...
- Patients with contraindications to dupilumab as per approved prescribing information
- Conditions that may interfere with study participation, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities preventing completion of assessments
- Current participation in any interventional clinical trial
- Use of dupilumab within 6 months before baseline assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who are treated with dupilumab as part of their routine clinical care are observed to describe the real-world effectiveness, safety, and patterns of use of the medication over time.
Regular visits during routine clinical care
Trial Site Locations
Total: 1 location
1
Virtual Research Coordination Center
Wilmington, North Carolina, United States, 28401-3331
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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