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

NCT ID: NCT07316114

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2029-11-22

Brief 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.

Conditions

Chronic Spontaneous Urticaria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Dupilumab

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Virtual Research Coordination Center

Wilmington, North Carolina, United States

Countries

United States

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

Contact-US@sanofi.com

800-633-1610 ext. option 6

Facility Contacts

Ghazaleh Bahrami

Role: primary

877-316-2285

Other Identifiers

U1111-1331-3693

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS18182

Identifier Type: -

Identifier Source: org_study_id