Actively Recruiting
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
Led by Sanofi · Updated on 2026-04-14
400
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 decision to treat the patient with dupilumab for chronic spontaneous urticaria made prior to and independently of study participation
- Patient can understand and complete study-related questionnaires
- Patients and/or parent or legally authorized representative provide voluntary informed consent and/or assent before joining the study
You will not qualify if you...
- Patients with contraindications to dupilumab according to its approved prescribing information
- Any condition that may interfere with the patient's ability to participate, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities preventing completion of assessments
- Patients currently enrolled in any interventional clinical trial
- Prior use of dupilumab within 6 months before baseline assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
CONTACT
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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