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

NCT04550962 | Active Not Recruiting

• 1 other identifier: OBS16688
• Study Type: observational
• Target: 376
• Locations: 12 countries
• Sites: 41

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• Baseline Characteristics: Socio-demographics

  Socio-demographics including but not limited to gender, age, race, weight, and height

  At baseline

• Baseline Characteristics: Medical history

  Including asthma history and asthma treatment history

  At baseline

• Baseline Characteristics: Disease characteristics

  Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases

  At baseline

• Baseline Characteristics: Biomarkers

  Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific)

  At baseline

• Baseline Characteristics: Concomitant treatments for asthma

  At baseline

Secondary Outcomes (9)

• Dupixent and other asthma treatment use patterns

  Baseline to Month 36

• Lung function

  Baseline to Month 36

• Annualized exacerbation rate

  Baseline to Month 36

• Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6)

  Baseline to Month 36

• Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis

  Baseline to Month 36

Study Arms (1)

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

Interventions

Dupilumab SAR231893 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen:

Also known as: Dupixent

Participants with asthma

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (41)

Investigational Site Number : 0320005

La Plata, Buenos Aires, B1900BNN, Argentina

Location

Investigational Site Number : 0320006

Villa Rosa, Buenos Aires, 1631, Argentina

Location

Investigational Site Number : 0320001

Ciudad Autonoma Bs As, C1121ABE, Argentina

Location

Investigational Site Number : 0320008

Ciudad Autonoma Buenos Aires, C1425BEN, Argentina

Location

Investigational Site Number : 0320009

San Miguel de Tucumán, T4000IAI, Argentina

Location

Investigational Site Number : 0320004

Santa Fe, 3000, Argentina

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

Location

Investigational Site Number : 1520002

Quillota, Región de Valparaíso, 2260877, Chile

Location

Investigational Site Number : 1700009

Barranquilla, 080001, Colombia

Location

Investigational Site Number : 1700004

Bogotá, Colombia

Location

Investigational Site Number : 1700003

Bucaramanga, Colombia

Location

Investigational Site Number : 3760008

Ashdod, 7747629, Israel

Location

Investigational Site Number : 3760004

Ashkelon, 78278, Israel

Location

Investigational Site Number : 3760005

Jerusalem, 91031, Israel

Location

Investigational Site Number : 3760003

Jerusalem, 91120, Israel

Location

Investigational Site Number : 3760001

Kfar Saba, 4428164, Israel

Location

Investigational Site Number : 3760006

Rehovot, 7642001, Israel

Location

Investigational Site Number : 3760007

Tel Aviv, 64239, Israel

Location

Investigational Site Number : 4140001

Kuwait City, 00000, Kuwait

Location

Investigational Site Number : 4220002

Beirut, 11 0236, Lebanon

Location

Investigational Site Number : 4220001

Beirut, Lebanon

Location

Investigational Site Number : 4220003

El Achrafiyé, Lebanon

Location

Investigational Site Number : 4840003

Durango, 34000, Mexico

Location

Investigational Site Number : 6340001

Doha, Qatar

Location

Investigational Site Number : 6430005

Chelyabinsk, 454091, Russia

Location

Investigational Site Number : 6430007

Moscow, 105077, Russia

Location

Investigational Site Number : 6430004

Moscow, 115522, Russia

Location

Investigational Site Number : 6430006

Rostov-on-Don, 344012, Russia

Location

Investigational Site Number : 6430008

Saratov, 410012, Russia

Location

Investigational Site Number : 6430002

Stavropol, 355020, Russia

Location

Investigational Site Number : 6820005

Jeddah, 23433, Saudi Arabia

Location

Investigational Site Number : 6820004

Mecca, 24246, Saudi Arabia

Location

Investigational Site Number : 6820002

Riyadh, 11525, Saudi Arabia

Location

Investigational Site Number : 6820001

Riyadh, 12713, Saudi Arabia

Location

Investigational Site Number : 7020002

Singapore, 119074, Singapore

Location

Investigational Site Number : 7020001

Singapore, 169308, Singapore

Location

Investigational Site Number : 7840006

Abu Dhabi, 0000, United Arab Emirates

Location

Investigational Site Number : 7840007

Dubai, 2, United Arab Emirates

Location

Investigational Site Number : 7840001

Dubai, 4545, United Arab Emirates

Location

Investigational Site Number : 7840004

Sharjah city, 00000, United Arab Emirates

Location

Investigational Site Number : 7840002

Sharjah city, 3499, United Arab Emirates

Location

Biospecimen

Retention: NONE RETAINED

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MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

SG (2); KU (1); AE (5); CL (2); QA (1); IL (7); RU (6); CO (3); AR (6); ME (1); LE (3); SA (4)