A Phase 3 interventional study of Dupilumab and Placebo in Wheezing and Asthma, sponsored by Sanofi. Enrolling by invitation at 74 sites in 16 countries. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Among 68 studies in Respiratory Sounds with a site in United States — 9 open to participants now, 12 under way, 1 of them phase 3. Respiratory Sounds · United States.
Among the 68 studies in Respiratory Sounds with a site in United States, this one is the 23rd largest by planned enrollment of the 39 interventional ones that give a count, is one of 3 that started in 2024, is one of 6 in phase 3, reaches primary completion later than 10 of the 11 other live ones, and was the 62nd registered.
189 studies on the registry are indexed under Respiratory Sounds; 41 are open to participants now.
This study's planned enrollment of 90 is below the median of 120 across 98 interventional studies indexed under Respiratory Sounds.
Browse Respiratory Sounds studies →9 of the 68 studies in Respiratory Sounds with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 31 Respiratory Sounds studies recruiting now, 6 (19%) set no upper age limit and 24 (77%) stop at 75 or younger; 21 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →68 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2024.
Median enrollment 140 across the 39 interventional studies, 150 across the 29 observational. Of the 51 that completed or were terminated, 17 (33%) have results posted.
26 of 68 have an industry lead sponsor. The 10 most frequent:
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Sanofi has 1 study filed under Respiratory Sounds — fewer than ten, so there is no comparison to draw.
5 of the studies in Respiratory Sounds with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06691971Aevice Health Pte. Ltd.AeviceMD for Detection of Wheeze in Pediatric and Adult Populations | 2026-12 |
| NCT06977581PfizerA Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma | 2027-03-08 |
| NCT07227376Eko Devices, Inc.Data Collection Using Eko Digital Devices in a Clinical Setting | 2027-04-01 |
| NCT05210361University of Colorado, DenverCritical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers | 2027-07 |
| NCT06106646Oregon Health and Science UniversityVitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up | 2027-08 |
Among the 68 studies in Respiratory Sounds with a site in United States, from their registry updates:
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.
Study details include:
Part A:
The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).
Part B:
For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
The duration per participant is up to 120 Weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one additional major criterion from the modified asthma predictive index:
Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
OR 2 minor criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dupilumab subcutaneous injection as per protocol
Drug: Dupilumab
Placebo matching dupilumab subcutaneous injection as per protocol
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Also known as: SAR231893, Dupixent
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period
Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Time frame: Baseline through Week 52
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation
Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.
Time frame: Week 52 through Week 116
Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.
Time frame: Baseline through Week 52
Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period
Annualized rate of moderate asthma exacerbations during the 52-week treatment period.
Time frame: Baseline through Week 52
Part A: Cumulative ICS dose during the 52-week treatment period
Time frame: Baseline through Week 52
Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period
Time frame: Baseline to Week 52
Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period
A day without asthma symptoms (DWAS) is defined as a day without any asthma symptoms, β-agonist use, oral steroid use, or need for urgent asthma care. The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms/interference) to 5 (very severe symptoms/interference). The overnight questions are scored on a 5-point scale from 0 (no overnight cough and caregiver not disturbed at all) to 4 (coughed all night and disturbed all night).
Time frame: Baseline through Week 52
Part A: Change from baseline to Week 52 in daytime symptom score using the daytime record of PACD
The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms/interference) to 5 (very severe symptoms/interference).
Time frame: Baseline to Week 52
Part A: Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation
Time frame: Baseline through Week 52
Part A: Change from baseline to Week 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale
PedsQL measures health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Scores range 0-100 with higher scores indicate better HRQOL.
Time frame: Baseline to Week 52
Part A: Caregiver Global Impression of Change in their child's asthma control (CGI-change in asthma control) at Week 52
CGI-change in asthma control is a 1-item questionnaire that asks the caregiver to provide the overall assessment of change of their child's asthma control on a 7-point scale, compared to just before he/she started taking the study treatment. Response choices are: 0 = "Very much better", 1 ="Moderately better", 2 = "A little better", 3 = "No change", 4 = "A little worse", 5 = "Moderately worse", 6 = "Very much worse".
Time frame: Week 52
Part A: Physician Global Assessment of Change of the child's asthma control (PGA-change in asthma control) at Week 52
The Physician Global Assessment of Change of Asthma (PGA-change in asthma control) is a 1 item questionnaire that asks the physician to provide the overall assessment of change in the child's asthma control on a 7-point scale, compared to just before he/she started taking the study treatment. Response choices are: 0 = "Very much better", 1 = "Moderately better", 2 ="A little better", 3 = "No change", 4 = "A little worse", 5 = "Moderately worse", 6 = "Very much worse".
Time frame: Week 52
Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma control (CGI-asthma control)
The Caregiver Global Impression of asthma control (CGI-Asthma Control) is a 1-item questionnaire that asks caregiver to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = "Not controlled", 2 = "Somewhat controlled", 3 = "Moderately controlled", 4 = "Well controlled".
Time frame: Baseline to Week 52
Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma severity (CGI-asthma severity)
The Caregiver Global Impression of asthma severity (CGI-Asthma Severity) is a 1-item questionnaire that asks caregivers to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe".
Time frame: Baseline to Week 52
Part A: Change from baseline to Week 52 in Physician Global Assessment of the child's asthma control (PGA-asthma control).
The Physician Global Assessment of asthma control is a 1-item questionnaire that asks physicians to assess the control of the child's asthma in the past 7 days on a 4 point scale for the past week. Response choices are: 1 = "Not controlled", 2 = "Somewhat controlled", 3 = "Moderately controlled", 4 = "Well controlled".
Time frame: Baseline to Week 52
Part A: Change from baseline to Week 52 in Test for Respiratory and Asthma Control in Kids (TRACK)
TRACK is a validated questionnaire for caregiver completion for preschool aged children with symptoms consistent with asthma. The total score range of 0 to 100. Higher scores indicated better asthma control.
Time frame: Baseline to Week 52
Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52
Time frame: Baseline to Week 24 and 52
Part A: Concentration of dupilumab in serum over time during the 52-week treatment period
Time frame: Baseline through Week 52
Part A: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab over time
Time frame: Baseline through Week 52
Part A: IgG response to any vaccination for tetanus, diphtheria and pertussis and antibody for influenza (HAI antibody titers) vaccine administered according to vaccination schedule during the 52-week treatment period
Time frame: Baseline through Week 52
Part B: Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period
Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period.
Time frame: Week 52 through Week 104
Part B Concentration of dupilumab in serum over time during the 52-week Part B treatment period
Time frame: Week 52 through Week 104
Part B: Incidence of treatment-emergent anti-drug antibodies (ADAs) against dupilumab over time
Time frame: Week 52 through Week 104
Plan to share: 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
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2028, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Dupilumab