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

Last updated: April 13, 2026
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hives (Urticaria)

Urticaria

Treatment

Dupilumab

Clinical Study ID

NCT07316114
OBS18182
U1111-1331-3693
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 spontaneousurticaria (CSU) made prior to and independently of the patient's participation inthe study.

  • Patient is able to understand and complete study-related questionnaires.

  • Patients and/or parent/legally authorized representative provide voluntary informedconsent and/or assent to participate in the study before inclusion in the study.

Exclusion

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the approvedprescribing information label.

  • Any condition that the treating physician or virtual Investigator believes mayinterfere with the patient's ability to participate in the study, such as short lifeexpectancy, substance abuse, severe cognitive impairment, or other comorbiditiesthat can predictably prevent the patient from completing the schedule ofassessments.

  • 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.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase:
Study Start date:
March 18, 2026
Estimated Completion Date:
November 22, 2029

Connect with a study center

  • Virtual Research Coordination Center

    Wilmington, North Carolina 28401-3331
    United States

    Active - Recruiting

  • Virtual Research Coordination Center

    Wilmington 4499379, North Carolina 4482348 28401-3331
    United States

    Site Not Available

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