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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04550962
Collaborator
Regeneron Pharmaceuticals (Industry)
800
Enrollment
40
Locations
73.6
Anticipated Duration (Months)
20
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dupilumab SAR231893

Detailed Description

Each patient will be followed during 36 months.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting
Actual Study Start Date :
Nov 2, 2020
Anticipated Primary Completion Date :
Dec 21, 2026
Anticipated Study Completion Date :
Dec 21, 2026

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Baseline Characteristics: Socio-demographics [At baseline]

    2. Baseline Characteristics: Medical history [At baseline]

      Including asthma history and asthma treatment history.

    3. Baseline Characteristics: Disease characteristics [At baseline]

    4. Baseline Characteristics: Concomitant treatments for asthma [At baseline]

    Secondary Outcome Measures

    1. Dupixent and other asthma treatment use patterns [Baseline to Month 54]

      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.

    2. Lung function [Baseline to Month 54]

      Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.

    3. Annualized exacerbation rate [Baseline to Month 54]

      An 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.

    4. Patient reported outcomes [Baseline to Month 54]

      For asthma and type 2 comorbidities over time.

    5. Healthcare Resource Utilization [Baseline to Month 54]

      The Healthcare Resource Utilization (HCRU) is a questionnaire filled out by the participating site at baseline and at clinical visits (scheduled and unscheduled) throughout the study.

    6. Number of participants with adverse events (AE) and serious adverse events (SAE) [Baseline to Month 54]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    • Most important exclusion criteria for potential participants 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :0320001 Ciudad de Buenos Aires Buenos Aires Argentina
    2 Investigational Site Number :0320009 San Miguel de Tucumán Tucumán Argentina T4000IAR
    3 Investigational Site Number :0320008 Ciudad Autonoma Buenos Aires Argentina C1425BEN
    4 Investigational Site Number :1520001 Santiago Reg Metropolitana De Santiago Chile 7500692
    5 Investigational Site Number :1520002 Quillota Valparaíso Chile 2260877
    6 Investigational Site Number :1700004 Bogota Colombia
    7 Investigational Site Number :1700003 Bucaramanga Colombia
    8 Investigational Site Number :3760008 Ashdod Israel 7747629
    9 Investigational Site Number :3760004 Ashkelon Israel 78278
    10 Investigational Site Number :3760005 Jerusalem Israel 91031
    11 Investigational Site Number :3760003 Jerusalem Israel 91120
    12 Investigational Site Number :3760001 Kfar Saba Israel 4428164
    13 Investigational Site Number :3760002 Petah-Tikva Israel 49100
    14 Investigational Site Number :3760006 Rehovot Israel 7642001
    15 Investigational Site Number :3760007 Tel Aviv Israel 64239
    16 Investigational Site Number :4140001 Kuwait Kuwait 00000
    17 Investigational Site Number :4220003 Achrafieh Lebanon
    18 Investigational Site Number :4220001 Beirut Lebanon
    19 Investigational Site Number :4220002 Beirut Lebanon
    20 Investigational Site Number :4840001 Guadalajara Jalisco Mexico 44100
    21 Investigational Site Number :4840003 Durango Mexico 34000
    22 Investigational Site Number :6340001 Doha Qatar
    23 Investigational Site Number :6430005 Chelyabinsk Russian Federation 454091
    24 Investigational Site Number :6430007 Moscow Russian Federation 105077
    25 Investigational Site Number :6430004 Moscow Russian Federation 115522
    26 Investigational Site Number :6430006 Rostov-on-Don Russian Federation 344012
    27 Investigational Site Number :6430008 Saratov Russian Federation 410012
    28 Investigational Site Number :6430002 Stavropol Russian Federation 355020
    29 Investigational Site Number :6820008 Jeddah Saudi Arabia 22252
    30 Investigational Site Number :6820005 Jeddah Saudi Arabia 23433
    31 Investigational Site Number :6820004 Makkah Saudi Arabia 24246
    32 Investigational Site Number :6820002 Riyadh Saudi Arabia 11525
    33 Investigational Site Number :6820001 Riyadh Saudi Arabia 12713
    34 Investigational Site Number :7020002 Singapore Singapore 119074
    35 Investigational Site Number :7020001 Singapore Singapore 169308
    36 Investigational Site Number :7840006 Abu Dhabi United Arab Emirates 0000
    37 Investigational Site Number :7840007 Dubai United Arab Emirates 2
    38 Investigational Site Number :7840001 Dubai United Arab Emirates 4545
    39 Investigational Site Number :7840004 Sharjah United Arab Emirates 00000
    40 Investigational Site Number :7840002 Sharjah United Arab Emirates 3499

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04550962
    Other Study ID Numbers:
    • OBS16688
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 30, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Jul 1, 2022