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

Study on Chronic Spontaneous Urticaria and Observational Use of an Investigational Medication

Recruiting
12 years or above
All
Phase N/A
400 participants needed
1 Location

Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Spontaneous Urticaria
  • Age: 12 years or above
  • Gender: All

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.

This study investigates chronic spontaneous urticaria (CSU) and aims to understand how patients respond to an investigational medication in real-world settings. The purpose of this study is to gather information on the condition and treatment from medical files and patient reports.

The study focuses on evaluating the safety and effectiveness of the investigational medication for patients with CSU. It seeks to collect data on usage patterns and how the treatment impacts patients' quality of life and work productivity.

  • Who can participate: Patients aged 12 years or older, who have been prescribed the investigational medication by their physician independently of the study, may join the study. Participants must be able to complete study questionnaires and provide informed consent.
  • Study details: Participants will provide information from their medical records and complete questionnaires about their condition and treatment. The study will observe how the investigational medication affects their daily lives and health.
  • Study timelines: The study will last 24 months.
Updated on 13 Apr 2026. Study ID: NCT07316114

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