Dupilumab for chronic spontaneous urticaria: real-world use and outcomes

A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria

This project will test whether dupilumab helps control symptoms and is safe for people aged 12 and older with chronic spontaneous urticaria in routine clinical care.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: dupilumab
• Locations: 1 site (Wilmington, North Carolina)
• Trial ID: NCT07316114 on ClinicalTrials.gov

What this trial studies

This decentralized U.S.-based project collects medical record data and patient-reported outcomes to describe how dupilumab is used and performs for chronic spontaneous urticaria outside of clinical trials. Patients whose treating physician has independently decided to prescribe dupilumab can self-screen, consent, and be enrolled through a Virtual Research Coordination Center. The study captures effectiveness, safety, patterns of use, quality of life, work productivity, and CSU-related hospitalizations using routine clinical data and questionnaires. No changes to prescribed clinical care are required, and data are collected from existing medical files and regular patient-reported assessments.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 years or older with chronic spontaneous urticaria whose physician has already decided to prescribe dupilumab and who can provide consent and complete study questionnaires.

Not a fit: Patients with a contraindication to dupilumab, those not prescribed dupilumab, or those with severe cognitive or medical issues preventing completion of assessments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could clarify how well dupilumab controls CSU symptoms and its safety in everyday practice, helping patients and clinicians make more informed treatment choices.

How similar studies have performed: Dupilumab is proven effective for related allergic diseases and small studies and case reports suggest potential benefit in CSU, but large-scale real-world evidence for dupilumab in CSU remains limited.

Eligibility criteria

Inclusion Criteria:

* Patients aged 12 years or older at the time of informed consent/assent.
* Physician decision to treat the patient with dupilumab for chronic spontaneous urticaria (CSU) made prior to and independently of the patient's participation in the study.
* Patient is able to understand and complete study-related questionnaires.
* Patients and/or parent/legally authorized representative provide voluntary informed consent and/or assent to participate in the study before inclusion in the study.

Exclusion Criteria:

* Patients who have a contraindication to dupilumab according to the approved prescribing information label.
* Any condition that the treating physician or virtual Investigator believes may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments.
* Patients currently participating in any interventional clinical trial.
* Prior use of dupilumab within 6 months of the baseline assessment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Wilmington, North Carolina

• Virtual Research Coordination Center — Wilmington, North Carolina, United States (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Chronic Spontaneous Urticaria