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

NCT07316114 | Recruiting FDA Drug

• 2 other identifiers: OBS18182U1111-1331-3693
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Summary of Sociodemographic Characteristics

  Sociodemographic and clinical characteristics, including but not limited to month and year of birth, age, sex, race, ethnicity, IgE levels, employment status, height, weight, and smoking status will be collected.

  Baseline

• Summary of Medical History of Chronic Spontaneous Urticaria (CSU)

  Medical history of CSU, including but not limited to CSU status and CSU treatment history will be collected.

  Baseline

• Summary of Type of Baseline Comorbidities

  Type of baseline comorbidities including atopic and non-atopic will be collected.

  Baseline

• Summary of Type of Concomitant Medication

  Type of concomitant medication will be collected.

  Baseline

• Summary of Healthcare Provider Specialties

  Healthcare practitioner's information (related to CSU treatment) and specialty (example, dermatology physician, dermatology nurse practitioner, dermatology physician assistant, allergy/immunology physician, allergy/immunology nurse practitioner, allergy/immunology physician assistant) will be collected.

  Baseline

• Summary of Dupilumab Dosing Regimen

  Summary of dupilumab dosing regimen, duration of treatment, time to discontinuation and other discontinuation details, and treatment modifications/interruptions and reasons will be collected.

  Baseline

• Summary of Treatments Used After Discontinuation

  Summary of treatments used after discontinuation will be collected.

  Baseline

• Summary of Participants Re-treated with Dupilumab and Reason

  Summary of participants re-treated with dupilumab and reason will be collected.

  Baseline

Secondary Outcomes (14)

• Change from Baseline in Disease Activity

  Baseline to up to 24 months

• Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds

  Baseline to up to 24 months

• Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds

  Baseline to up to 24 months

• Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab

  Baseline to up to 24 months

• Dupilumab Treatment Details: Duration of Disease Control

  Baseline to up to 24 months

Interventions

Dupilumab DRUG

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to enroll approximately 10% to 20% adolescents (that is, participants aged 12 to 17 years) of the total 400 participants. If the adolescent enrollment target is not met toward the end of the period, adult enrollment may be temporarily paused to allow more adolescents to enroll.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Virtual Research Coordination Center

Wilmington, North Carolina, 28401-3331, United States

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 5, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 22, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)