AsthmaPhase 3NCT03560466
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
A Phase 3 study testing Dupilumab (SAR231893/REGN668) and Asthma reliever therapies in people with Asthma, run by Sanofi at 81 sites in 18 countries.
Trial summary
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab (SAR231893/REGN668) and Asthma reliever therapies
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 81 sitesin 18 countries
- Study dates
- 21 Jun 2018to 1 Apr 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
- Signed written informed consent/assent. Specific for Brazil: EFC14153 patients from Brazil, who prematurely discontinued Investigational Medicinal Product (IMP) to receive Yellow Fever vaccine (a live attenuated vaccine) during Yellow Fever outbreak, are allowed to be enrolled in LTS14424 after completing the required procedures in EFC14153 (completion of remaining visits and procedures until end of treatment (EOT) V28, considered as V1 for LTS14424).
- Patients who are not able to complete their treatment in Study EFC14153 due to the COVID-19 pandemic will be allowed to enroll into Study LTS14424. Patients who enroll in LTS14424 after completing the EFC14153 EOS visit should have eligibility for LTS14424 reevaluated including background medication check and laboratory assessments (including complete blood count [CBC] with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1.
- For Japan sub-study
- Signed written inform consent/assent
- Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to screening
- Blood eosinophil count ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥20 parts per billion (ppb) at screening visit (Visit 0).
Who cannot join
- Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.
- Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).
- Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study.
- Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study.
- Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient's participation in this study or would require permanent IMP discontinuation.
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- For female patients who have commenced menstruating at any time during the study and are either:
- Found to have a positive urine pregnancy test, or
- Sexually active, not using an established acceptable contraceptive method.
- Planned live, attenuated vaccinations during the study.
- Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment.
- For Japan sub-study:
- Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.
- Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).
- Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study at the screening and enrollment visits.
- Patients who previously have been treated with dupilumab
- Diagnosed with active parasitic infection (helminthes); suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per Investigator's judgment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
81 sites in 18 countries.
81 sites in 18 countries
United States12 sites
Immunocarolina LLC Site Number : 8400004
Charlotte, North Carolina, 28277
Cincinnati Children's Hospital Medical Center Site Number : 8400008
Cincinnati, Ohio, 45229
OK Clinical Research, LLC- Site Number : 8400024
Edmond, Oklahoma, 73034
Arizona Allergy and Immunology Research- Site Number : 8400002
Gilbert, Arizona, 85234
Northwell Health- Site Number : 8400023
Great Neck, New York, 11021
Somnos Clinical Research Site Number : 8400022
Lincoln, Nebraska, 68505
Columbia University Medical Center- Site Number : 8400013
New York, New York, 10032
Rochester Regional Health- Site Number : 8400007
Rochester, New York, 14607
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, 90274
Allergy & Asthma Research Center- Site Number : 8400003
San Antonio, Texas, 78229
Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006
St Louis, Missouri, 63110-1077
Asthma and Airway Disease Research Center Site Number : 8400012
Tucson, Arizona, 85274
Japan11 sites
Investigational Site Number : 3920013
Chiba, Chiba, 266-0007
Investigational Site Number : 3920016
Chuo-ku, Chiba, 260-0001
Investigational Site Number : 3920015
Fukuoka, Fukuoka, 811-1394
Investigational Site Number : 3920011
Fukuoka, Fukuoka, 813-0017
Investigational Site Number : 3920009
Habikino-Shi, 583-0872
Investigational Site Number : 3920014
Onomichi-shi, Hiroshima, 722-8508
Investigational Site Number : 3920003
Sapporo, Hokkaido, 064-0821
Investigational Site Number : 3920008
Shibukawa, Gunma, 377-8577
Investigational Site Number : 3920012
Tsu, Mie-ken, 514-0125
Investigational Site Number : 3920010
Ureshino-shi, Saga-ken, 843-0393
Investigational Site Number : 3920005
Yotsukaido-shi, Chiba, 284-0003
Hungary7 sites
Investigational Site Number : 3480006
Budapest, 1089
Investigational Site Number : 3480002
Gyula, 5700
Investigational Site Number : 3480012
Mezőkövesd, 3400
Investigational Site Number : 3480001
Székesfehérvár, 8000
Investigational Site Number : 3480008
Szigetvár, 7900
Investigational Site Number : 3480003
Töröbálint, 2045
Investigational Site Number : 3480007
Zalaegerszeg, 8900
Ukraine7 sites
Investigational Site Number : 8040007
Chernivtsi, 58023
Investigational Site Number : 8040004
Dnipro, 49101
Investigational Site Number : 8040005
Kharkiv, 61093
Investigational Site Number : 8040008
Kryvyi Rig, 50082
Investigational Site Number : 8040001
Kyiv, 03115
Investigational Site Number : 8040002
Zaporizhzhya, 69063
Investigational Site Number : 8040003
Zaporizhzhya, 69076
Argentina5 sites
Investigational Site Number : 0320003
Buenos Aires, C1121ABE
Investigational Site Number : 0320002
CABA, Buenos Aires, C1122AAK
Investigational Site Number : 0320001
CABA, Buenos Aires, C1414AIF
Investigational Site Number : 0320006
Mendoza, 5500
Investigational Site Number : 0320004
Vicente Lopez, Buenos Aires F.D., B1602DQD
Brazil5 sites
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital Sao Lucas da PUCRS- Site Number : 0760007
Porto Alegre, Rio Grande do Sul, 90610-000
Unidade Ambulatorial de Pesquisa Clinica I - NGP - UNIFESP- Site Number : 0760002
São Paulo, São Paulo, 04037-002
Instituto da Criança of Hospital das Clínicas de São Paulo- Site Number : 0760004
São Paulo, São Paulo, 05403-000
Clinica de Alergia Martti Antila Site Number : 0760006
Sorocaba, São Paulo, 18040-425
Chile5 sites
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 838-0418
Investigational Site Number : 1520009
Santiago, Reg Metropolitana de Santiago, 8380453
Investigational Site Number : 1520001
Valdivia, Los Ríos Region, 5090145
Investigational Site Number : 1520007
Viña del Mar, Valparaiso, 2520024
Investigational Site Number : 1520002
Viña del Mar, Valparaiso, 2520594
Mexico5 sites
Investigational Site Number : 4840006
Chihuahua City, 31000
Investigational Site Number : 4840004
Chihuahua City, 31200
Investigational Site Number : 4840003
Durango, Durango, 34080
Investigational Site Number : 4840001
Monterrey, Nuevo León, 64460
Investigational Site Number : 4840002
Veracruz, 91910
Russia5 sites
Investigational Site Number : 6430004
Perm, 614066
Investigational Site Number : 6430002
Saint Petersburg, 193312
Investigational Site Number : 6430001
Saint Petersburg, 194100
Investigational Site Number : 6430003
Saint Petersburg, 196158
Investigational Site Number : 6430005
Saint Petersburg, 197101
Lithuania4 sites
Investigational Site Number : 4400005
Šiauliai, LT-76231
Investigational Site Number : 4400003
Utena, LT-28151
Investigational Site Number : 4400001
Vilnius, LT-08406
Investigational Site Number : 4400004
Vilnius, LT-09108
Turkey (Türkiye)4 sites
Investigational Site Number : 7920005
Adana, 01339
Investigational Site Number : 7920001
Ankara
Investigational Site Number : 7920003
Istanbul
Investigational Site Number : 7920004
Istanbul
Italy3 sites
Investigational Site Number : 3800003
Florence, 50139
Investigational Site Number : 3800004
Padova, 35128
Investigational Site Number : 3800005
Roma, 00146
Colombia2 sites
Investigational Site Number : 1700004
Antioquia, 050010
Investigational Site Number : 1700002
Cali, 760043
Poland2 sites
Investigational Site Number : 6160001
Lodz, Lódzkie, 90-329
Investigational Site Number : 6160002
Poznan, Greater Poland Voivodeship, 60-693
Australia1 site
Investigational Site Number : 0360005
North Adelaide, South Australia, 5006
Spain1 site
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08035
About this study
Official title: One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Primary Objective:
- To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study.
Read more
Secondary Objectives:
- To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to:
- Systemic exposure.
- Anti-drug antibodies (ADAs).
- Biomarkers.
- To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study
- To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to:
- Systemic exposure,
- Anti-drug antibodies (ADAs),
- Biomarkers
Read the detailed description
Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.
Japan substudy:
Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.
- Conditions
- Asthma
- Being tested
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab (SAR231893/REGN668)Drug
Pharmaceutical form: solution for injection
Route of administration: subcutaneous (sc)
Asthma controller therapies (incl. prednisone/prednisolone)Drug
Pharmaceutical form: powder, or solution, or pill
Route of administration: inhaled, oral or parenteral
Asthma reliever therapiesDrug
Pharmaceutical form: powder or solution
Route of administration: inhaled
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks Receives: Drug: Dupilumab (SAR231893/REGN668); Drug: Asthma controller therapies (incl. prednisone/prednisolone); Drug: Asthma reliever therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.
Measured: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study.
Measured: Baseline (Day 1) to Week 12
Secondary outcomes (14)
Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.
Measured: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period
A severe exacerbation event during study was defined as a deterioration of asthma requiring use of systemic corticosteroid (SCS) for ≥3 days or hospitalization/emergency room visit because of asthma, requiring SCS. Annualized severe exacerbation event rate was defined as total number of events that occurred during 52-week treatment period divided by total number of participant-years followed in 52-week treatment period.
Measured: Up to Week 52
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time
FEV1 was volume of air (in liters) exhaled from the lungs in first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time
FEV1 was volume of air (in liters) exhaled from the lungs in first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Forced Vital Capacity (FVC) Over Time
FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline (main study):original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time
FEF was defined as amount of air which can be forcibly exhaled from lungs in first second of forced exhalation. FEF 25-75% was the mean FEF between 25% and 75% of FVC. FVC was defined as volume of air that could be forcibly blown out after full inspiration in upright position. Spirometry was performed after wash out period of bronchodilators. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time
FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline was defined as the original baseline of parent study EFC14153.
Measured: Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time
ACQ-7-IA had 7 questions with first 5 items of ACQ-7 addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma, wheeze; 2 questions on short-acting bronchodilator use and predicted bronchodilator use of FEV1. Participants/parents/guardians recalled child's previous week asthma and responded to questions on 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-7-IA score was the mean of 7 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time
The ACQ-5-IA had 5 questions addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze. Participants/parents/guardians recalled the child's previous week asthma and responded to symptom and bronchodilator use questions on a 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-5-IA score was the mean of 5 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64
Serum Concentrations of Dupilumab
Blood samples were collected at the specified timepoints for determination of functional dupilumab concentration in serum.
Measured: Weeks 12, 24, 52 and 64
Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab
ADA positive was defined as either treatment-boosted or treatment-emergent response in the ADA assay. Treatment-boosted response was defined as a positive response in the ADA assay post first dose in the current study that was greater than or equal to 4-fold of the baseline titer levels, when baseline results were positive. Treatment-emergent response was defined as a positive response in the ADA assay post first dose in the current study, when baseline results were negative or missing. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: From first dose of study treatment (Day 1) to Week 64
Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64
Blood samples were collected at specified timepoints to assess percent change from baseline in eosinophil count. Baseline was defined as the original baseline of parent study EFC14153.
Measured: Baseline (Day 1) to Week 64
Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64
Blood samples were collected at specified timepoints to assess percent change from baseline in total IgE in serum. Baseline (main study): the original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.
Measured: Baseline (Day 1) to Week 64
Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64
FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second. FeNO assessment was conducted prior to spirometry and following a fast of ≥1 hour. Baseline was defined as the last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in the current study.
Measured: Baseline (Day 1) to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start21 Jun 2018
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560466
- Sponsor's protocol ID
- LTS14424
- Other IDs
- U1111-1200-1757, 2017-003317-25, 2017
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2018
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Dell S, Guilbert TW, Deschildre A, Phipatanakul W, Papadopoulos NG, Murray CS, Xia C, Moraco A, Shams M, Bacharier LB. Dupilumab outcomes in pediatric asthma by early eosinophil status: Post hoc analysis of VOYAGE/EXCURSION. J Allergy Clin Immunol. 2026 Sep;158(3):727-738. doi: 10.1016/j.jaci.2026.06.012. Epub 2026 Jun 30.
PubMed 42379525Phipatanakul W, Vogelberg C, Bacharier LB, Dell S, Altincatal A, Gall R, Ledanois O, Sacks H, Jacob-Nara JA, Deniz Y, Rowe PJ. Dupilumab 200 mg was efficacious in children (6-11 years) with moderate-to-severe asthma for up to 2 years: EXCURSION open-label extension study. Pediatr Pulmonol. 2024 Nov;59(11):2976-2983. doi: 10.1002/ppul.27167. Epub 2024 Jul 17.
PubMed 39016623Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, Guilbert TW, Jackson DJ, Staudinger HW, Laws E, Mannent LP, Akinlade B, Maloney J, Tawo K, Khokhar FA, Li N, Hardin M, Abdulai RM, Lederer DJ, Robinson LB; Liberty Asthma EXCURSION Investigators. Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2024 Jan;12(1):45-54. doi: 10.1016/S2213-2600(23)00303-X. Epub 2023 Nov 10.
PubMed 37956679
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
- ClinicalTrials.gov ID
- NCT03560466
- Acronym / sponsor ID
- LTS14424
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study.
Secondary Objectives:
- To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to:
- Systemic exposure.
- Anti-drug antibodies (ADAs).
- Biomarkers.
- To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study
- To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to:
- Systemic exposure,
- Anti-drug antibodies (ADAs),
- Biomarkers
Detailed description
Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.
Japan substudy:
Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: Dupilumab (SAR231893/REGN668), Drug: Asthma controller therapies (incl. prednisone/prednisolone), Drug: Asthma reliever therapiesDoses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
- Signed written informed consent/assent. Specific for Brazil: EFC14153 patients from Brazil, who prematurely discontinued Investigational Medicinal Product (IMP) to receive Yellow Fever vaccine (a live attenuated vaccine) during Yellow Fever outbreak, are allowed to be enrolled in LTS14424 after completing the required procedures in EFC14153 (completion of remaining visits and procedures until end of treatment (EOT) V28, considered as V1 for LTS14424).
- Patients who are not able to complete their treatment in Study EFC14153 due to the COVID-19 pandemic will be allowed to enroll into Study LTS14424. Patients who enroll in LTS14424 after completing the EFC14153 EOS visit should have eligibility for LTS14424 reevaluated including background medication check and laboratory assessments (including complete blood count [CBC] with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1.
- For Japan sub-study
- Signed written inform consent/assent
Key exclusion criteria (19 listed)
- Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.
- Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).
- Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study.
- Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study.
- Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumab (SAR231893/REGN668)Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc) | Drug | Dupilumab |
| Asthma controller therapies (incl. prednisone/prednisolone)Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral | Drug | Dupilumab |
| Asthma reliever therapiesPharmaceutical form: powder or solution Route of administration: inhaled | Drug | Dupilumab |
Primary outcome
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (Day 1) to Week 12
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study.
14 secondary outcomes
Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events
Time frame: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period
Time frame: Up to Week 52
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Forced Vital Capacity (FVC) Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time
Time frame: Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64
Serum Concentrations of Dupilumab
Time frame: Weeks 12, 24, 52 and 64
Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab
Time frame: From first dose of study treatment (Day 1) to Week 64
Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64
Time frame: Baseline (Day 1) to Week 64
Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64
Time frame: Baseline (Day 1) to Week 64
Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64
Time frame: Baseline (Day 1) to Week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42379525Dell S, Guilbert TW, Deschildre A, Phipatanakul W, Papadopoulos NG, Murray CS, Xia C, Moraco A, Shams M, Bacharier LB. Dupilumab outcomes in pediatric asthma by early eosinophil status: Post hoc analysis of VOYAGE/EXCURSION. J Allergy Clin Immunol. 2026 Sep;158(3):727-738. doi: 10.1016/j.jaci.2026.06.012. Epub 2026 Jun 30.
- Derived from this study: PubMed 39016623Phipatanakul W, Vogelberg C, Bacharier LB, Dell S, Altincatal A, Gall R, Ledanois O, Sacks H, Jacob-Nara JA, Deniz Y, Rowe PJ. Dupilumab 200 mg was efficacious in children (6-11 years) with moderate-to-severe asthma for up to 2 years: EXCURSION open-label extension study. Pediatr Pulmonol. 2024 Nov;59(11):2976-2983. doi: 10.1002/ppul.27167. Epub 2024 Jul 17.
- Derived from this study: PubMed 37956679Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, Guilbert TW, Jackson DJ, Staudinger HW, Laws E, Mannent LP, Akinlade B, Maloney J, Tawo K, Khokhar FA, Li N, Hardin M, Abdulai RM, Lederer DJ, Robinson LB; Liberty Asthma EXCURSION Investigators. Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2024 Jan;12(1):45-54. doi: 10.1016/S2213-2600(23)00303-X. Epub 2023 Nov 10.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
81 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dupilumab (SAR231893/REGN668) and Asthma reliever therapies in people with Asthma, run by Sanofi at 81 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Japan, Hungary, Ukraine, Argentina and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560466, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.