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NCT07316114 · ClinicalTrials.gov registry record
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
A clinical trial of Chronic Spontaneous Urticaria, sponsored by Sanofi.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT07316114: Recruiting study of Chronic Spontaneous Urticaria, sponsored by Sanofi.
NCT07316114 is a study of Chronic Spontaneous Urticaria that is actively recruiting participants, run by Sanofi. The registered enrollment target is 400 participants, below the 1,405-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07316114, a study of Chronic Spontaneous Urticaria, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (1)
North Carolina
- Virtual Research Coordination Center - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-02-28 |
| Est. Completion | 2029-11-22 |
What NCT07316114 shows while recruiting
NCT07316114 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,405-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT07316114 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07316114 about?
NCT07316114 is a clinical study titled "A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria". 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 it...
What is the current status of trial NCT07316114?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2026-02-28. Estimated completion is 2029-11-22.
What conditions does trial NCT07316114 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT07316114?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT07316114?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07316114 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07316114's enrollment target sits among peer trials
400 9th of 18 higher than 10 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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