AsthmaREVEALNCT04550962
Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
An observational study of Asthma, run by Sanofi at 41 sites in 12 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab SAR231893
- Type of treatment
- Injection or infusion
- How many people
- 376 participants
- Where
- 41 sitesin 12 countries
- Study dates
- 2 Nov 2020to 18 Jun 2026
- Phase
- Observational
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: Patients with asthma initiating DUPIXENT for their asthma according to the prescribing information in effect in each country.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
41 sites in 12 countries.
41 sites in 12 countries
Israel7 sites
Investigational Site Number : 3760008
Ashdod, 7747629
Investigational Site Number : 3760004
Ashkelon, 78278
Investigational Site Number : 3760005
Jerusalem, 91031
Investigational Site Number : 3760003
Jerusalem, 91120
Investigational Site Number : 3760001
Kfar Saba, 4428164
Investigational Site Number : 3760006
Rehovot, 7642001
Investigational Site Number : 3760007
Tel Aviv, 64239
Argentina6 sites
Investigational Site Number : 0320001
Ciudad Autonoma Bs As, C1121ABE
Investigational Site Number : 0320008
Ciudad Autonoma Buenos Aires, C1425BEN
Investigational Site Number : 0320005
La Plata, Buenos Aires, B1900BNN
Investigational Site Number : 0320009
San Miguel de Tucumán, T4000IAI
Investigational Site Number : 0320004
Santa Fe, 3000
Investigational Site Number : 0320006
Villa Rosa, Buenos Aires, 1631
Russia6 sites
Investigational Site Number : 6430005
Chelyabinsk, 454091
Investigational Site Number : 6430007
Moscow, 105077
Investigational Site Number : 6430004
Moscow, 115522
Investigational Site Number : 6430006
Rostov-on-Don, 344012
Investigational Site Number : 6430008
Saratov, 410012
Investigational Site Number : 6430002
Stavropol, 355020
United Arab Emirates5 sites
Investigational Site Number : 7840006
Abu Dhabi, 0000
Investigational Site Number : 7840007
Dubai, 2
Investigational Site Number : 7840001
Dubai, 4545
Investigational Site Number : 7840004
Sharjah city, 00000
Investigational Site Number : 7840002
Sharjah city, 3499
Saudi Arabia4 sites
Investigational Site Number : 6820005
Jeddah, 23433
Investigational Site Number : 6820004
Mecca, 24246
Investigational Site Number : 6820002
Riyadh, 11525
Investigational Site Number : 6820001
Riyadh, 12713
Colombia3 sites
Investigational Site Number : 1700009
Barranquilla, 080001
Investigational Site Number : 1700004
Bogotá
Investigational Site Number : 1700003
Bucaramanga
Lebanon3 sites
Investigational Site Number : 4220002
Beirut, 11 0236
Investigational Site Number : 4220001
Beirut
Investigational Site Number : 4220003
El Achrafiyé
Chile2 sites
Investigational Site Number : 1520002
Quillota, Valparaiso, 2260877
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500692
Singapore2 sites
Investigational Site Number : 7020002
Singapore, 119074
Investigational Site Number : 7020001
Singapore, 169308
About this study
Official title: 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.
Read more
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.
Read the detailed description
Each patient will be followed for up to 36 months.
- Conditions
- Asthma
- Being tested
- Dupilumab SAR231893
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab SAR231893Drug
Also called Dupixent
Pharmaceutical form:solution Route of administration: subcutaneous
Dose regimen:
| Study group | Role | What they receive |
|---|---|---|
| Participants with asthma | Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country Receives: Drug: Dupilumab SAR231893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Characteristics: Socio-demographics
Socio-demographics including but not limited to gender, age, race, weight, and height
Measured: At baseline
Baseline Characteristics: Medical history
Including asthma history and asthma treatment history
Measured: At baseline
Baseline Characteristics: Disease characteristics
Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases
Measured: At baseline
Baseline Characteristics: Biomarkers
Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific)
Measured: At baseline
Baseline Characteristics: Concomitant treatments for asthma
Measured: At baseline
Secondary outcomes (9)
Dupixent and other asthma treatment use patterns
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.
Measured: Baseline to Month 36
Lung function
Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.
Measured: Baseline to Month 36
Annualized exacerbation rate
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.
Measured: Baseline to Month 36
Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6)
To evaluate asthma control
Measured: Baseline to Month 36
Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis
Among participants with atopic dermatitis
Measured: Baseline to Month 36
Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis
Among participants with allergic rhinitis
Measured: Baseline to Month 36
Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22)
Among participants with chronic rhinosinusitis with nasal polyps [CRSwNP] and chronic rhinosinusitis [CRS] without nasal polyps [NP])
Measured: Baseline to Month 36
Healthcare Resource Utilization
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
Measured: Baseline to Month 36
Number of participants with adverse events (AE) and serious adverse events (SAE)
Measured: Baseline to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start2 Nov 2020
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550962
- Sponsor's protocol ID
- OBS16688
- Acronym
- REVEAL
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Publications
Maspero JF, Arnaout RK, Vargas-Ramirez L, Mobayed H, Mahboub B, Irani C, Bar-Shai A, Koh MS, Chao J, Zaghloul S, Kwah JH, Dewhurst J, Al-Ahmad MS. Baseline Characteristics of Patients with Asthma Initiating Dupilumab in a Real-World Setting: The REVEAL Registry. Adv Ther. 2026 Jun 10. doi: 10.1007/s12325-026-03623-2. Online ahead of print.
PubMed 42268495