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Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Primary Purpose

Asthma

Status

Recruiting

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
- Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
- Treatment with medium to high dose inhaled corticosteroids (ICS) (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1.
- Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization
- Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.
- Bronchodilator reversibility (≥ 12% and 200 mL improvement in FEV1 post short-acting beta agonists (SABA) administration) during the screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 12 months prior to Visit 1.
- FeNO ≥35 ppb at Visit 2, prior to randomization. Up to 550 patients can be enrolled with baseline FeNO<35 ppb at Visit 2
- History of ≥1 severe exacerbation(s) in the previous year before V1 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. - - - -

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).
Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.
Current acute bronchospasm or status asthmaticus.
Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.
Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms [CRFs], etc).
Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.
Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.
History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
Previous smoker with a smoking history >10 pack-years.
History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.
Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.

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

Sites / Locations

Cullman Research Center, LLC-Site Number:8400001Recruiting
Syed Research Consultants, LLC-Site Number:8400015Recruiting
Chandler Clinical Trials (Elite Clinical Network)-Site Number:8400147Recruiting
MACOA-Site Number:8400130Recruiting
Del Sol Research Management, LLC-Site Number:8400017Recruiting
Kern Research, Inc-Site Number:8400037Recruiting
Vitality Clinical Research-Site Number:8400142Recruiting
ASCADA Research-Site Number:8400076
NewportNativeMD, Inc-Site Number:8400054Recruiting
Prospective Research Innovations Inc.-Site Number:8400131Recruiting
Allianz Research Institute-Site Number:8400018Recruiting
Central Florida Pulmonary Group, PA-Site Number:8400035Recruiting
Florida Center for Allergy and Asthma Research-Site Number:8400032Recruiting
Pulmonary & Sleep of Tampa Bay-Site Number:8400046Recruiting
Beautiful Minds Clinical Research Center-Site Number:8400141Recruiting
Omega Research-Site Number:8400023Recruiting
Florida Lung, Asthma, and Sleep Specialists-Site Number:8400098Recruiting
Floridian Clinical Research-Site Number:8400091Recruiting
Biotech Pharmaceutical Group, LLC-Site Number:8400073Recruiting
Ivetmar Medical Group LLC-Site Number:8400063Recruiting
Research Institute of South Florida-Site Number:8400079Recruiting
HMD Research LLC-Site Number:8400024Recruiting
JSV Clinical Research Study, Inc-Site Number:8400150Recruiting
Appalachian Clinical Research-Site Number:8400129Recruiting
Alpha Clinical Research Georgia-Site Number:8400116Recruiting
Aeroallergy Research Laboratories Of Savannah Inc-Site Number:8400114Recruiting
NorthShore University HealthSystem Clinical Trials Center-Site Number:8400138Recruiting
Allergy & Asthma Specialists, PSC-Site Number:8400007Recruiting
Avant Research Associates LLC-Site Number:8400117Recruiting
Javara Inc-Site Number:8400087Recruiting
Allergy Asthma Specialists of Maryland-Site Number:8400119Recruiting
Genesis Clinical Research & Consulting-Site Number:8400050Recruiting
University of Michigan-Site Number:8400030Recruiting
Revival Research Institute, LLC-Site Number:8400097Recruiting
Revive Research Institute-Site Number:8400100Recruiting
Romedica, LLC-Site Number:8400043
Great Lakes Research Institute-Site Number:8400111Recruiting
Respiratory Medicine Research Institute of Michigan, PLC-Site Number:8400107Recruiting
Nebraska Medical Research Institute, Inc.-Site Number:8400055Recruiting
Urban Health Plan-Site Number:8400144Recruiting
Mid Hudson Medical Research PLLC-Site Number:8400031Recruiting
Tryon Medical Partners-Site Number:8400088Recruiting
Clinical Research of Gastonia-Site Number:8400012Recruiting
Advanced Respiratory and Sleep Medicine-Site Number:8400151Recruiting
Advanced Respiratory and Sleep Medicine-Site Number:8400056Recruiting
Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400112Recruiting
Southeastern Research Center-Site Number:8400153Recruiting
Toledo Institute of Clinical Research-Site Number:8400051Recruiting
Vital Prospects Clinical Research Institute, P.C.-Site Number:8400093Recruiting
St. Luke's University Health Network-Site Number:8400099Recruiting
Temple Lung Center-Site Number:8400038Recruiting
Allergy & Clinical Immunology Associates-Site Number:8400042Recruiting
National Allergy and ENT-Site Number:8400092Recruiting
Bogan Sleep Consultants-Site Number:8400102Recruiting
ADAC Research, PA-Site Number:8400026Recruiting
Main Street Physician's Care-Site Number:8400077
Health Concepts-Site Number:8400006Recruiting
REX Clinical Trials-Site Number:8400135Recruiting
TTS Research-Site Number:8400009Recruiting
DCT-Baxter Research, LLC dba Discovery Clinical Trials-Site Number:8400123Recruiting
C & R Research Services USA-Site Number:8400067Recruiting
Biopharma Informatic-Site Number:8400062Recruiting
Houston Pulmonary Sleep, Allergy and Asthma Associates-Site Number:8400049Recruiting
Clear Brook Medical Associates-Site Number:8400080Recruiting
Metroplex Pulmonary and Sleep Center-Site Number:8400014Recruiting
Texas Institute of Cardiology-Site Number:8400003Recruiting
Andante Research-Site Number:8400140Recruiting
DM Clinical Research-Site Number:8400103Recruiting
University of Virginia-Site Number:8400082Recruiting
Investigational Site Number :0560002Recruiting
Investigational Site Number :0560001Recruiting
Investigational Site Number :0560003Recruiting
Investigational Site Number :0760006Recruiting
Investigational Site Number :0760003Recruiting
Investigational Site Number :0760005Recruiting
Investigational Site Number :0760002Recruiting
Investigational Site Number :0760007Recruiting
Investigational Site Number :0760008Recruiting
Investigational Site Number :1000005Recruiting
Investigational Site Number :1000003Recruiting
Investigational Site Number :1000011Recruiting
Investigational Site Number :1000008Recruiting
Investigational Site Number :1240020Recruiting
Investigational Site Number :1240004Recruiting
Investigational Site Number :1240010Recruiting
Investigational Site Number :1240015Recruiting
Investigational Site Number :1240005Recruiting
Investigational Site Number :1240021Recruiting
Investigational Site Number :1240018Recruiting
Investigational Site Number :1240011Recruiting
Investigational Site Number :1240001Recruiting
Investigational Site Number :1240007Recruiting
Investigational Site Number :1240014Recruiting
Investigational Site Number :1240002Recruiting
Investigational Site Number :1240003Recruiting
Investigational Site Number :3000003Recruiting
Investigational Site Number :3000006Recruiting
Investigational Site Number :3000010Recruiting
Investigational Site Number :3000007Recruiting
Investigational Site Number :3000004Recruiting
Investigational Site Number :3000005Recruiting
Investigational Site Number :3000002Recruiting
Investigational Site Number :3000008Recruiting
Investigational Site Number :3000009Recruiting
Investigational Site Number :3000001Recruiting
Investigational Site Number :3480011Recruiting
Investigational Site Number :3480012Recruiting
Investigational Site Number :3480008Recruiting
Investigational Site Number :3480005Recruiting
Investigational Site Number :3480004Recruiting
Investigational Site Number :3480007Recruiting
Investigational Site Number :3480003Recruiting
Investigational Site Number :3480013Recruiting
Investigational Site Number :3480006Recruiting
Investigational Site Number :3480001Recruiting
Investigational Site Number :3560011Recruiting
Investigational Site Number :3560003Recruiting
Investigational Site Number :3560008Recruiting
Investigational Site Number :3560016Recruiting
Investigational Site Number :3560001Recruiting
Investigational Site Number :3560002Recruiting
Investigational Site Number :3560014Recruiting
Investigational Site Number :3560006Recruiting
Investigational Site Number :3560017Recruiting
Investigational Site Number :3560018Recruiting
Investigational Site Number :3560005Recruiting
Investigational Site Number :3560009Recruiting
Investigational Site Number :3560012Recruiting
Investigational Site Number :3560015Recruiting
Investigational Site Number :3560004Recruiting
Investigational Site Number :3720001Recruiting
Investigational Site Number :4100007Recruiting
Investigational Site Number :4100006Recruiting
Investigational Site Number :4100008Recruiting
Investigational Site Number :4100010Recruiting
Investigational Site Number :4100002Recruiting
Investigational Site Number :4100009Recruiting
Investigational Site Number :4100001Recruiting
Investigational Site Number :4100004Recruiting
Investigational Site Number :4100005Recruiting
Investigational Site Number :4100003Recruiting
Investigational Site Number :4840013Recruiting
Investigational Site Number :4840002Recruiting
Investigational Site Number :4840008Recruiting
Investigational Site Number :4840005Recruiting
Investigational Site Number :4840014Recruiting
Investigational Site Number :4840001Recruiting
Investigational Site Number :4840006Recruiting
Investigational Site Number :4840003Recruiting
Cardiopulmonary Research-Site Number:8400126Recruiting
FDI Clinical Research-Site Number:8400121Recruiting
University of Puerto Rico Medical Sciences Campus-Site Number:8400128Recruiting
Investigational Site Number :7030003Recruiting
Investigational Site Number :7030001Recruiting
Investigational Site Number :7030004Recruiting
Investigational Site Number :7030002Recruiting
Investigational Site Number :7030005Recruiting
Investigational Site Number :7100006Recruiting
Investigational Site Number :7100008Recruiting
Investigational Site Number :7100001Recruiting
Investigational Site Number :7100003Recruiting
Investigational Site Number :7100009Recruiting
Investigational Site Number :7100004Recruiting
Investigational Site Number :7100007Recruiting
Investigational Site Number :7100010Recruiting
Investigational Site Number :7100005Recruiting
Investigational Site Number :7100002Recruiting
Investigational Site Number :1580001Recruiting
Investigational Site Number :1580005Recruiting
Investigational Site Number :1580004Recruiting
Investigational Site Number :1580002Recruiting
Investigational Site Number :1580003Recruiting
Investigational Site Number :7840001Recruiting
Investigational Site Number :8260004Recruiting
Investigational Site Number :8260008Recruiting
Investigational Site Number :8260002Recruiting
Investigational Site Number :8260005Recruiting
Investigational Site Number :8260001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Placebo

Arm Description

Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1

Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1

Outcomes

Primary Outcome Measures

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population

Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.

Secondary Outcome Measures

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.

Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population

Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.

Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations

Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.

Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations

Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.

Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations

Exacerbation 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.

Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations

Change from baseline to week 52 in FeNO levels in FeNO and Total populations.

Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations

ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.

Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations

Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.

Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations

Change from baseline to week 52 in FVC in FeNO and Total populations.

Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population

Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.

Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations

Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.

Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations

Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.

Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations

Change from baseline to week 104 in FeNO levels in FeNO and Total populations

Change from baseline to week 104 in FeNO levels in FeNO and Total populations.

Change from baseline to week 104 in ACQ-7 in FeNO and Total populations

Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations

Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.

Change from baseline to week 104 FVC in FeNO and Total populations

Change from baseline to week 104 FVC in FeNO and Total populations.

Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations

The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.

Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations

Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations

Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Incidence of TEAEs and SAEs.

Incidence of adverse events of special interest (AESIs)

Incidence of AESIs.

Full Information

NCT ID

NCT05097287

First Posted

October 15, 2021

Last Updated

August 11, 2023

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05097287

Brief Title

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Official Title

A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

August 11, 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 16, 2021 (Actual)

Primary Completion Date

June 28, 2025 (Anticipated)

Study Completion Date

October 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1828 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dupilumab

Arm Type

Experimental

Arm Description

Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Intervention Description

solution for injection subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

solution for injection subcutaneous

Primary Outcome Measure Information:

Title

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population

Description

Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.

Time Frame

Week 8 to Week 52

Secondary Outcome Measure Information:

Title

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population

Description

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.

Time Frame

Week 8 to Week 52

Title

Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population

Description

Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.

Time Frame

Week 8 to Week 104

Title

Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations

Description

Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.

Time Frame

Baseline to Week 52

Title

Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations

Description

Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.

Time Frame

Baseline to Week 52

Title

Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations

Description

Time Frame

Baseline to Week 52

Title

Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations

Description

Change from baseline to week 52 in FeNO levels in FeNO and Total populations.

Time Frame

Baseline to Week 52

Title

Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations

Description

Time Frame

Baseline to Week 52

Title

Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations

Description

Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.

Time Frame

Baseline to Week 52

Title

Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations

Description

Change from baseline to week 52 in FVC in FeNO and Total populations.

Time Frame

Baseline to Week 52

Title

Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population

Description

Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.

Time Frame

Week 8 to Week 104

Title

Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations

Description

Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.

Time Frame

Baseline to Week 104

Title

Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations

Description

Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.

Time Frame

Baseline to Week 104

Title

Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations

Description

Time Frame

Baseline to Week 104

Title

Change from baseline to week 104 in FeNO levels in FeNO and Total populations

Description

Change from baseline to week 104 in FeNO levels in FeNO and Total populations.

Time Frame

Baseline to Week 104

Title

Change from baseline to week 104 in ACQ-7 in FeNO and Total populations

Description

Time Frame

Baseline to Week 104

Title

Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations

Description

Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.

Time Frame

Baseline to Week 104

Title

Change from baseline to week 104 FVC in FeNO and Total populations

Description

Change from baseline to week 104 FVC in FeNO and Total populations.

Time Frame

Baseline to Week 104

Title

Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations

Description

Time Frame

Baseline to Week 52

Title

Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations

Description

Time Frame

Baseline to Week 104

Title

Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations

Description

Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.

Time Frame

Week 8 to Week 156

Title

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Description

Incidence of TEAEs and SAEs.

Time Frame

Baseline to Week 168

Title

Incidence of adverse events of special interest (AESIs)

Description

Incidence of AESIs.

Time Frame

Baseline to Week 168

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent. Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months Treatment with medium to high dose inhaled corticosteroids (ICS) (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1. Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization. Bronchodilator reversibility (≥ 12% and 200 mL improvement in FEV1 post short-acting beta agonists (SABA) administration) during the screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 12 months prior to Visit 1. FeNO ≥35 ppb at Visit 2, prior to randomization. Up to 550 patients can be enrolled with baseline FeNO<35 ppb at Visit 2 History of ≥1 severe exacerbation(s) in the previous year before V1 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. - - - - Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome). Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period. Current acute bronchospasm or status asthmaticus. Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms [CRFs], etc). Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator. Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period. History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit). Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1. Previous smoker with a smoking history >10 pack-years. History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient. Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer. Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Trial Transparency email recommended (Toll free number for US & Canada)

Phone

800-633-1610

Ext

option 6

Contact-US@sanofi.com

Facility Information:

Facility Name

Cullman Research Center, LLC-Site Number:8400001

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35055

Country

United States

Individual Site Status

Recruiting

Facility Name

Syed Research Consultants, LLC-Site Number:8400015

City

Sheffield

State/Province

Alabama

ZIP/Postal Code

35660

Country

United States

Individual Site Status

Recruiting

Facility Name

Chandler Clinical Trials (Elite Clinical Network)-Site Number:8400147

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85286

Country

United States

Individual Site Status

Recruiting

Facility Name

MACOA-Site Number:8400130

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Individual Site Status

Recruiting

Facility Name

Del Sol Research Management, LLC-Site Number:8400017

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Individual Site Status

Recruiting

Facility Name

Kern Research, Inc-Site Number:8400037

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Individual Site Status

Recruiting

Facility Name

Vitality Clinical Research-Site Number:8400142

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Individual Site Status

Recruiting

Facility Name

ASCADA Research-Site Number:8400076

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

NewportNativeMD, Inc-Site Number:8400054

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Name

Prospective Research Innovations Inc.-Site Number:8400131

City

Rancho Cucamonga

State/Province

California

ZIP/Postal Code

91730

Country

United States

Individual Site Status

Recruiting

Facility Name

Allianz Research Institute-Site Number:8400018

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Individual Site Status

Recruiting

Facility Name

Central Florida Pulmonary Group, PA-Site Number:8400035

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Individual Site Status

Recruiting

Facility Name

Florida Center for Allergy and Asthma Research-Site Number:8400032

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Individual Site Status

Recruiting

Facility Name

Pulmonary & Sleep of Tampa Bay-Site Number:8400046

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Individual Site Status

Recruiting

Facility Name

Beautiful Minds Clinical Research Center-Site Number:8400141

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Individual Site Status

Recruiting

Facility Name

Omega Research-Site Number:8400023

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Individual Site Status

Recruiting

Facility Name

Florida Lung, Asthma, and Sleep Specialists-Site Number:8400098

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34746

Country

United States

Individual Site Status

Recruiting

Facility Name

Floridian Clinical Research-Site Number:8400091

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Individual Site Status

Recruiting

Facility Name

Biotech Pharmaceutical Group, LLC-Site Number:8400073

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Recruiting

Facility Name

Ivetmar Medical Group LLC-Site Number:8400063

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Institute of South Florida-Site Number:8400079

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Individual Site Status

Recruiting

Facility Name

HMD Research LLC-Site Number:8400024

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Individual Site Status

Recruiting

Facility Name

JSV Clinical Research Study, Inc-Site Number:8400150

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Individual Site Status

Recruiting

Facility Name

Appalachian Clinical Research-Site Number:8400129

City

Adairsville

State/Province

Georgia

ZIP/Postal Code

30103

Country

United States

Individual Site Status

Recruiting

Facility Name

Alpha Clinical Research Georgia-Site Number:8400116

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30350

Country

United States

Individual Site Status

Recruiting

Facility Name

Aeroallergy Research Laboratories Of Savannah Inc-Site Number:8400114

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Individual Site Status

Recruiting

Facility Name

NorthShore University HealthSystem Clinical Trials Center-Site Number:8400138

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Individual Site Status

Recruiting

Facility Name

Allergy & Asthma Specialists, PSC-Site Number:8400007

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Individual Site Status

Recruiting

Facility Name

Avant Research Associates LLC-Site Number:8400117

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Individual Site Status

Recruiting

Facility Name

Javara Inc-Site Number:8400087

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Individual Site Status

Recruiting

Facility Name

Allergy Asthma Specialists of Maryland-Site Number:8400119

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Individual Site Status

Recruiting

Facility Name

Genesis Clinical Research & Consulting-Site Number:8400050

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02723

Country

United States

Individual Site Status

Recruiting

Facility Name

University of Michigan-Site Number:8400030

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Name

Revival Research Institute, LLC-Site Number:8400097

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48126

Country

United States

Individual Site Status

Recruiting

Facility Name

Revive Research Institute-Site Number:8400100

City

Lathrup Village

State/Province

Michigan

ZIP/Postal Code

48076

Country

United States

Individual Site Status

Recruiting

Facility Name

Romedica, LLC-Site Number:8400043

City

Rochester

State/Province

Michigan

ZIP/Postal Code

48307

Country

United States

Individual Site Status

Completed

Facility Name

Great Lakes Research Institute-Site Number:8400111

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48075

Country

United States

Individual Site Status

Recruiting

Facility Name

Respiratory Medicine Research Institute of Michigan, PLC-Site Number:8400107

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Individual Site Status

Recruiting

Facility Name

Nebraska Medical Research Institute, Inc.-Site Number:8400055

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123

Country

United States

Individual Site Status

Recruiting

Facility Name

Urban Health Plan-Site Number:8400144

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Individual Site Status

Recruiting

Facility Name

Mid Hudson Medical Research PLLC-Site Number:8400031

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553-7754

Country

United States

Individual Site Status

Recruiting

Facility Name

Tryon Medical Partners-Site Number:8400088

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Individual Site Status

Recruiting

Facility Name

Clinical Research of Gastonia-Site Number:8400012

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Individual Site Status

Recruiting

Facility Name

Advanced Respiratory and Sleep Medicine-Site Number:8400151

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Individual Site Status

Recruiting

Facility Name

Advanced Respiratory and Sleep Medicine-Site Number:8400056

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Individual Site Status

Recruiting

Facility Name

Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400112

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Individual Site Status

Recruiting

Facility Name

Southeastern Research Center-Site Number:8400153

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103-4027

Country

United States

Individual Site Status

Recruiting

Facility Name

Toledo Institute of Clinical Research-Site Number:8400051

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Individual Site Status

Recruiting

Facility Name

Vital Prospects Clinical Research Institute, P.C.-Site Number:8400093

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74138

Country

United States

Individual Site Status

Recruiting

Facility Name

St. Luke's University Health Network-Site Number:8400099

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Individual Site Status

Recruiting

Facility Name

Temple Lung Center-Site Number:8400038

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Individual Site Status

Recruiting

Facility Name

Allergy & Clinical Immunology Associates-Site Number:8400042

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Individual Site Status

Recruiting

Facility Name

National Allergy and ENT-Site Number:8400092

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Individual Site Status

Recruiting

Facility Name

Bogan Sleep Consultants-Site Number:8400102

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Individual Site Status

Recruiting

Facility Name

ADAC Research, PA-Site Number:8400026

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Individual Site Status

Recruiting

Facility Name

Main Street Physician's Care-Site Number:8400077

City

Little River

State/Province

South Carolina

ZIP/Postal Code

29566

Country

United States

Individual Site Status

Completed

Facility Name

Health Concepts-Site Number:8400006

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Individual Site Status

Recruiting

Facility Name

REX Clinical Trials-Site Number:8400135

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77701-3713

Country

United States

Individual Site Status

Recruiting

Facility Name

TTS Research-Site Number:8400009

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Individual Site Status

Recruiting

Facility Name

DCT-Baxter Research, LLC dba Discovery Clinical Trials-Site Number:8400123

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Individual Site Status

Recruiting

Facility Name

C & R Research Services USA-Site Number:8400067

City

Houston

State/Province

Texas

ZIP/Postal Code

77022

Country

United States

Individual Site Status

Recruiting

Facility Name

Biopharma Informatic-Site Number:8400062

City

Houston

State/Province

Texas

ZIP/Postal Code

77043

Country

United States

Individual Site Status

Recruiting

Facility Name

Houston Pulmonary Sleep, Allergy and Asthma Associates-Site Number:8400049

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Individual Site Status

Recruiting

Facility Name

Clear Brook Medical Associates-Site Number:8400080

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Individual Site Status

Recruiting

Facility Name

Metroplex Pulmonary and Sleep Center-Site Number:8400014

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Individual Site Status

Recruiting

Facility Name

Texas Institute of Cardiology-Site Number:8400003

City

McKinney

State/Province

Texas

ZIP/Postal Code

75071

Country

United States

Individual Site Status

Recruiting

Facility Name

Andante Research-Site Number:8400140

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Name

DM Clinical Research-Site Number:8400103

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Individual Site Status

Recruiting

Facility Name

University of Virginia-Site Number:8400082

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0560002

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0560001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0560003

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760006

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760003

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90020-090

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760005

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760002

City

Blumenau

State/Province

Santa Catarina

ZIP/Postal Code

89030-100

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760007

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01327-001

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :0760008

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1000005

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1000003

City

Montana

ZIP/Postal Code

3400

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1000011

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1000008

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240020

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1W 3H5

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240004

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240010

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1G 5C4

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240015

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240005

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240021

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4V 1P1

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240018

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2H 1H5

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240011

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240001

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240007

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240014

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240002

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1240003

City

Windsor

ZIP/Postal Code

N8X 5A6

Country

Canada

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000003

City

Athens

ZIP/Postal Code

10675

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000006

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000010

City

Athens

ZIP/Postal Code

11521

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000007

City

Athens

ZIP/Postal Code

11525

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000004

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000005

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000002

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000008

City

N. Efkarpia

ZIP/Postal Code

56429

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000009

City

Palaio Faliro, Athens

ZIP/Postal Code

17562

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3000001

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480011

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480012

City

Budapest

ZIP/Postal Code

1203

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480008

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480005

City

Edelény

ZIP/Postal Code

3780

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480004

City

Hajdunánás

ZIP/Postal Code

4080

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480007

City

Mosonmagyaróvár

ZIP/Postal Code

9200

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480003

City

Puspokladany

ZIP/Postal Code

4150

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480013

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480006

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3480001

City

Százhalombatta

ZIP/Postal Code

2440

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560011

City

Ahmedabad

ZIP/Postal Code

380060

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560003

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560008

City

Coimbatore

ZIP/Postal Code

641028

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560016

City

Faridabad

ZIP/Postal Code

121001

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560001

City

Jaipur

ZIP/Postal Code

302023

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560002

City

Kozhikode

ZIP/Postal Code

673008

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560014

City

Lucknow

ZIP/Postal Code

226006

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560006

City

Mangalore

ZIP/Postal Code

575003

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560017

City

Mumbai

ZIP/Postal Code

400008

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560018

City

Mysore

ZIP/Postal Code

570001

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560005

City

Mysore

ZIP/Postal Code

570004

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560009

City

Nagpur

ZIP/Postal Code

440012

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560012

City

Nagpur

ZIP/Postal Code

440012

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560015

City

New Delhi

ZIP/Postal Code

110025

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3560004

City

Vadodara

ZIP/Postal Code

390021

Country

India

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :3720001

City

Wilton

State/Province

Cork

Country

Ireland

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100007

City

Busan

State/Province

Busan-gwangyeoksi

ZIP/Postal Code

602-739

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100006

City

Daegu

State/Province

Daegu-gwangyeoksi

ZIP/Postal Code

705-717

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100008

City

Wonju

State/Province

Gangwon-do

ZIP/Postal Code

26426

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100010

City

Incheon

State/Province

Incheon-gwangyeoksi

ZIP/Postal Code

21431

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100002

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100009

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

03312

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100001

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

05030

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100004

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100005

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4100003

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

138-878

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840013

City

Oxaca

State/Province

Ciudad De Mexico

ZIP/Postal Code

68020

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840002

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840008

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64710

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840005

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

66465

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840014

City

San Juan del Rio

State/Province

Querétaro

ZIP/Postal Code

76800

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840001

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840006

City

Mexico

ZIP/Postal Code

06700

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :4840003

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Cardiopulmonary Research-Site Number:8400126

City

Guaynabo

ZIP/Postal Code

00968

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Name

FDI Clinical Research-Site Number:8400121

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Name

University of Puerto Rico Medical Sciences Campus-Site Number:8400128

City

San Juan

ZIP/Postal Code

00936

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7030003

City

Levice

ZIP/Postal Code

93401

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7030001

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7030004

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7030002

City

Spisska Nova Ves

ZIP/Postal Code

05201

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7030005

City

Topolcany

ZIP/Postal Code

955 01

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100006

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100008

City

Cape Town

ZIP/Postal Code

7130

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100001

City

Cape Town

ZIP/Postal Code

7937

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100003

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100009

City

Durban

ZIP/Postal Code

4302

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100004

City

Gatesville

ZIP/Postal Code

4001

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100007

City

Gauteng

ZIP/Postal Code

1935

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100010

City

Johannesburg

ZIP/Postal Code

1619

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100005

City

Parow

ZIP/Postal Code

7500

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7100002

City

Pretoria

ZIP/Postal Code

0145

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1580001

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1580005

City

New Taipei City

ZIP/Postal Code

220

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1580004

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1580002

City

Taipei

ZIP/Postal Code

110

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :1580003

City

Yunlin

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :7840001

City

Abu Dhabi

ZIP/Postal Code

000000

Country

United Arab Emirates

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :8260004

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 OQQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :8260008

City

Wakefield

State/Province

Leeds

ZIP/Postal Code

WF1 1PL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :8260002

City

Bradford

ZIP/Postal Code

BD9 6DA

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :8260005

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Investigational Site Number :8260001

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Links:

URL

https://www.asthmaclinicalstudies.com/?utm_source=ctgov&utm_medium=website

Description

LPS16676 Asthma clinical study website

Learn more about this trial

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

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