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NCT07316114: DEDICATION

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

Recruiting now Last updated 14 April 2026
What this trial tests

trial testing Dupilumab in Chronic Spontaneous Urticaria in 400 participants. Currently enrolling.

Timeline
18 March 2026
Primary endpoint
24 November 2027
22 November 2029

Quick facts

Lead sponsorSanofi
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment400
Start date18 March 2026
Primary completion24 November 2027
Estimated completion22 November 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi — full company profile →

Who can join

12 and older, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Dupilumab

Trials testing the same drug.

Other recruiting trials for Chronic Spontaneous Urticaria

Currently open trials in the same condition.

Other Sanofi trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07316114.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing