Chronic Spontaneous UrticariaDEDICATIONNCT07316114
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
An observational study of Chronic Spontaneous Urticaria, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Dupilumab
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 2 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtual Research Coordination Center
Wilmington, North Carolina, 28401-3331
About this study
Official title: A Prospective Observational Study of Patients Receiving Dupilumab for 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 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
- Being tested
- Dupilumab
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Summary of Type of Baseline Comorbidities
Type of baseline comorbidities including atopic and non-atopic will be collected.
Measured: Baseline
Summary of Type of Concomitant Medication
Type of concomitant medication will be collected.
Measured: 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.
Measured: 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.
Measured: Baseline
Summary of Treatments Used After Discontinuation
Summary of treatments used after discontinuation will be collected.
Measured: Baseline
Summary of Participants Re-treated with Dupilumab and Reason
Summary of participants re-treated with dupilumab and reason will be collected.
Measured: Baseline
Secondary outcomes (14)
Change from Baseline in Disease Activity
Change from baseline in disease activity as assessed by Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT) scores.
Measured: Baseline to up to 24 months
Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds
Summary of participants who achieve response thresholds, including onset of response, peak response, recapture response will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.
Measured: Baseline to up to 24 months
Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds
Summary of participants who achieve disease control thresholds will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.
Measured: Baseline to up to 24 months
Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab
Durability of response will be assessed by using Urticaria Activity Score over 7 days (UAS7). It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Measured: Baseline to up to 24 months
Dupilumab Treatment Details: Duration of Disease Control
Duration of disease control prior to and after discontinuation of dupilumab will be assessed.
Measured: Baseline to up to 24 months
Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Adult Participants
The CU-Q2oL is a patient-reported outcome measure designed to assess the impact of chronic urticaria on various aspects of a patient's life. It includes questions that evaluate physical symptoms, emotional well-being, daily activities, sleep quality, and treatment satisfaction. Responses are scored on a 5-point Likert scale, reflecting the overall QoL impairment, with higher scores indicating greater negative impact.
Measured: Baseline to up to 24 months
Change from Baseline in Dermatology Life Quality Index (DLQI) for Participants 16 years of Age or Older
The DLQI is a 10-question, patient-reported outcome measure designed to assess the impact of skin diseases on the QoL.24 It covers domains such as symptoms, emotional well-being, leisure activities, school performance, personal relationships, and treatment burden. Each question is scored from 0 to 3, with a total score ranging from 0 to 30, where higher scores indicate greater impairment.
Measured: Baseline to up to 24 months
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) for Participants 15 Years of Age or Younger
The CDLQI is a 10-question, patient-reported outcome measure designed to assess the impact of skin diseases on the QoL.24 It covers domains such as symptoms, emotional well-being, leisure activities, school performance, personal relationships, , and treatment burden. Each question is scored from 0 to 3, with a total score ranging from 0 to 30, where higher scores indicate greater impairment.
Measured: Baseline to up to 24 months
Change from Baseline in Work Productivity and Activity Impairment: Chronic urticaria (WPAI:CU) for Adult Participants
The WPAI:CU is a 6-item PRO instrument that measures the effect of a condition on productivity during work and regular activities in the 7 days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to chronic urticaria. WPAI:CU outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Baseline to up to 24 months
Change from Baseline in Treatment satisfaction (TSQM-9) for Adult Participants
The TSQM-9 is a 9-item PRO measure designed to evaluate satisfaction with medication across 3 domains: effectiveness, side effects, and convenience.27 It uses a 5- or 7-point Likert scale to score responses, which are then transformed to a 0-100 scale, with higher scores indicating greater satisfaction.
Measured: Baseline to up to 24 months
CSU-related Hospitalization
CSU-related hospitalization including number of hospital visits, number of emergency department visits, number of specialist visits will be collected.
Measured: Baseline to up to 24 months
Number of Particiapants Experiencing Adverse Events
Number of participants experiencing AEs will be assessed.
Measured: Baseline to up to 24 months
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of participants experiencing SAEs will be assessed.
Measured: Baseline to up to 24 months
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Number of participants experiencing AESI will be assessed.
Measured: Baseline to up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start18 Mar 2026
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Why it stopped: Sponsor decision; the decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316114
- Sponsor's protocol ID
- OBS18182
- Other IDs
- U1111-1331-3693
- Acronym
- DEDICATION
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07316114
- Acronym / sponsor ID
- DEDICATION / OBS18182
- Conditions
- Chronic Spontaneous Urticaria
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision; the decision is not related to any safety concern.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabThis study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. | Drug | – |
Primary outcome
Summary of Sociodemographic Characteristics
Time frame: Baseline
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.
Summary of Medical History of Chronic Spontaneous Urticaria (CSU)
Time frame: Baseline
Medical history of CSU, including but not limited to CSU status and CSU treatment history will be collected.
Summary of Type of Baseline Comorbidities
Time frame: Baseline
Type of baseline comorbidities including atopic and non-atopic will be collected.
Summary of Type of Concomitant Medication
Time frame: Baseline
Type of concomitant medication will be collected.
Summary of Healthcare Provider Specialties
Time frame: Baseline
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.
Summary of Dupilumab Dosing Regimen
Time frame: Baseline
Summary of dupilumab dosing regimen, duration of treatment, time to discontinuation and other discontinuation details, and treatment modifications/interruptions and reasons will be collected.
Summary of Treatments Used After Discontinuation
Time frame: Baseline
Summary of treatments used after discontinuation will be collected.
Summary of Participants Re-treated with Dupilumab and Reason
Time frame: Baseline
Summary of participants re-treated with dupilumab and reason will be collected.
14 secondary outcomes
Change from Baseline in Disease Activity
Time frame: Baseline to up to 24 months
Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds
Time frame: Baseline to up to 24 months
Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds
Time frame: Baseline to up to 24 months
Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab
Time frame: Baseline to up to 24 months
Dupilumab Treatment Details: Duration of Disease Control
Time frame: Baseline to up to 24 months
Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Adult Participants
Time frame: Baseline to up to 24 months
Change from Baseline in Dermatology Life Quality Index (DLQI) for Participants 16 years of Age or Older
Time frame: Baseline to up to 24 months
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) for Participants 15 Years of Age or Younger
Time frame: Baseline to up to 24 months
Change from Baseline in Work Productivity and Activity Impairment: Chronic urticaria (WPAI:CU) for Adult Participants
Time frame: Baseline to up to 24 months
Change from Baseline in Treatment satisfaction (TSQM-9) for Adult Participants
Time frame: Baseline to up to 24 months
CSU-related Hospitalization
Time frame: Baseline to up to 24 months
Number of Particiapants Experiencing Adverse Events
Time frame: Baseline to up to 24 months
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Baseline to up to 24 months
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Time frame: Baseline to up to 24 months
Results and safety
The study was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Sociodemographic Characteristics (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.