Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT) (REVEAL)

February 10, 2026 updated by: Sanofi

PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting

Primary Objective:

The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma.

Secondary Objectives:

The secondary objectives of the study are:

  • To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching)
  • To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control)
  • To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent
  • To collect data on HealthCare Resource Utilization (HCRU)
  • To collect safety data on study participants in the real-world setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each patient will be followed for up to 36 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free number for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Argentina
      • Ciudad Autonoma Bs As, Argentina, C1121ABE
        • Investigational Site Number : 0320001
      • Ciudad Autonoma Buenos Aires, Argentina, C1425BEN
        • Investigational Site Number : 0320008
      • San Miguel de Tucumán, Argentina, T4000IAI
        • Investigational Site Number : 0320009
      • Santa Fe, Argentina, 3000
        • Investigational Site Number : 0320004
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900BNN
        • Investigational Site Number : 0320005
      • Villa Rosa, Buenos Aires, Argentina, 1631
        • Investigational Site Number : 0320006
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
        • Investigational Site Number : 1520001
    • Región de Valparaíso
      • Quillota, Región de Valparaíso, Chile, 2260877
        • Investigational Site Number : 1520002
  • Colombia
      • Barranquilla, Colombia, 080001
        • Investigational Site Number : 1700009
      • Bogotá, Colombia
        • Investigational Site Number : 1700004
      • Bucaramanga, Colombia
        • Investigational Site Number : 1700003
  • Israel
      • Ashdod, Israel, 7747629
        • Investigational Site Number : 3760008
      • Ashkelon, Israel, 78278
        • Investigational Site Number : 3760004
      • Jerusalem, Israel, 91031
        • Investigational Site Number : 3760005
      • Jerusalem, Israel, 91120
        • Investigational Site Number : 3760003
      • Kfar Saba, Israel, 4428164
        • Investigational Site Number : 3760001
      • Rehovot, Israel, 7642001
        • Investigational Site Number : 3760006
      • Tel Aviv, Israel, 64239
        • Investigational Site Number : 3760007
  • Kuwait
      • Kuwait City, Kuwait, 00000
        • Investigational Site Number : 4140001
  • Lebanon
      • Beirut, Lebanon, 11 0236
        • Investigational Site Number : 4220002
      • Beirut, Lebanon
        • Investigational Site Number : 4220001
      • El Achrafiyé, Lebanon
        • Investigational Site Number : 4220003
  • Mexico
      • Durango, Mexico, 34000
        • Investigational Site Number : 4840003
  • Qatar
      • Doha, Qatar
        • Investigational Site Number : 6340001
  • Russia
      • Chelyabinsk, Russia, 454091
        • Investigational Site Number : 6430005
      • Moscow, Russia, 105077
        • Investigational Site Number : 6430007
      • Moscow, Russia, 115522
        • Investigational Site Number : 6430004
      • Rostov-on-Don, Russia, 344012
        • Investigational Site Number : 6430006
      • Saratov, Russia, 410012
        • Investigational Site Number : 6430008
      • Stavropol, Russia, 355020
        • Investigational Site Number : 6430002
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 23433
        • Investigational Site Number : 6820005
      • Mecca, Saudi Arabia, 24246
        • Investigational Site Number : 6820004
      • Riyadh, Saudi Arabia, 11525
        • Investigational Site Number : 6820002
      • Riyadh, Saudi Arabia, 12713
        • Investigational Site Number : 6820001
  • Singapore
      • Singapore, Singapore, 119074
        • Investigational Site Number : 7020002
      • Singapore, Singapore, 169308
        • Investigational Site Number : 7020001
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 0000
        • Investigational Site Number : 7840006
      • Dubai, United Arab Emirates, 2
        • Investigational Site Number : 7840007
      • Dubai, United Arab Emirates, 4545
        • Investigational Site Number : 7840001
      • Sharjah city, United Arab Emirates, 00000
        • Investigational Site Number : 7840004
      • Sharjah city, United Arab Emirates, 3499
        • Investigational Site Number : 7840002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with asthma initiating DUPIXENT for their asthma according to the prescribing information in effect in each country.

Description

Inclusion Criteria:

  • Male or female, 12 years or older
  • Initiating treatment with Dupixent for asthma according to the country-specific prescribing information
  • Willing and able to comply with the required clinic visits, study procedures and assessments.
  • Provided signed informed consent

Exclusion Criteria:

  • Patients who have a contraindication to Dupixent according to the country-specific prescribing information
  • Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1.
  • Any condition that, in the opinion of the Investigator, may interfere with 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 adequately completing the schedule of visits and assessments
  • Patients currently participating in any interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with asthma
Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country
Drug: Dupilumab SAR231893

Pharmaceutical form:solution Route of administration: subcutaneous

Dose regimen:

Other Names:
  • Dupixent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline Characteristics: Concomitant treatments for asthma
Time Frame: At baseline
At baseline
Baseline Characteristics: Socio-demographics
Time Frame: At baseline
Socio-demographics including but not limited to gender, age, race, weight, and height
At baseline
Baseline Characteristics: Medical history
Time Frame: At baseline
Including asthma history and asthma treatment history
At baseline
Baseline Characteristics: Disease characteristics
Time Frame: At baseline
Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases
At baseline
Baseline Characteristics: Biomarkers
Time Frame: At baseline
Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific)
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dupixent and other asthma treatment use patterns
Time Frame: Baseline to Month 36
Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching.
Baseline to Month 36
Lung function
Time Frame: Baseline to Month 36
Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.
Baseline to Month 36
Annualized exacerbation rate
Time Frame: Baseline to Month 36

A severe exacerbation event is defined as a deterioration of asthma requiring:

  • Use of systemic corticosteroids for ≥3 days; or
  • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Baseline to Month 36
Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6)
Time Frame: Baseline to Month 36
To evaluate asthma control
Baseline to Month 36
Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis
Time Frame: Baseline to Month 36
Among participants with atopic dermatitis
Baseline to Month 36
Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis
Time Frame: Baseline to Month 36
Among participants with allergic rhinitis
Baseline to Month 36
Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22)
Time Frame: Baseline to Month 36
Among participants with chronic rhinosinusitis with nasal polyps [CRSwNP] and chronic rhinosinusitis [CRS] without nasal polyps [NP])
Baseline to Month 36
Healthcare Resource Utilization
Time Frame: Baseline to Month 36
The Healthcare Resource Utilization (HCRU) collects information on unscheduled healthcare resource encounters including inpatient visits, emergency room visits, physician office visits related to asthma, including the dates of visits and duration of any hospitalizations, together with the reason for the visits
Baseline to Month 36
Number of participants with adverse events (AE) and serious adverse events (SAE)
Time Frame: Baseline to Month 36
Baseline to Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBS16688

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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