Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

NCT03560466 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: LTS14424U1111-1200-17572017-003317-25
• Study Type: interventional
• Target: 378
• Locations: 18 countries
• Sites: 81

Brief 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. 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (Day 1) to Week 12

Secondary Outcomes (14)

• Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events

  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

  Up to Week 52

• Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time

  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

  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

  Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64

Study Arms (1)

Dupilumab

EXPERIMENTAL

Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks

Drug: Dupilumab (SAR231893/REGN668); Drug: Asthma controller therapies (incl. prednisone/prednisolone); Drug: Asthma reliever therapies

Interventions

Dupilumab (SAR231893/REGN668) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)

Dupilumab

Asthma controller therapies (incl. prednisone/prednisolone) DRUG

Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral

Dupilumab

Asthma reliever therapies DRUG

Pharmaceutical form: powder or solution Route of administration: inhaled

Dupilumab

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (81)

Arizona Allergy and Immunology Research- Site Number : 8400002

Gilbert, Arizona, 85234, United States

Location

Asthma and Airway Disease Research Center Site Number : 8400012

Tucson, Arizona, 85274, United States

Location

Peninsula Research Associates Site Number : 8400001

Rolling Hills Estates, California, 90274, United States

Location

Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006

St Louis, Missouri, 63110-1077, United States

Location

Somnos Clinical Research Site Number : 8400022

Lincoln, Nebraska, 68505, United States

Location

Northwell Health- Site Number : 8400023

Great Neck, New York, 11021, United States

Location

Columbia University Medical Center- Site Number : 8400013

New York, New York, 10032, United States

Location

Rochester Regional Health- Site Number : 8400007

Rochester, New York, 14607, United States

Location

Immunocarolina LLC Site Number : 8400004

Charlotte, North Carolina, 28277, United States

Location

Cincinnati Children's Hospital Medical Center Site Number : 8400008

Cincinnati, Ohio, 45229, United States

Location

OK Clinical Research, LLC- Site Number : 8400024

Edmond, Oklahoma, 73034, United States

Location

Allergy & Asthma Research Center- Site Number : 8400003

San Antonio, Texas, 78229, United States

Location

Investigational Site Number : 0320002

CABA, Buenos Aires, C1122AAK, Argentina

Location

Investigational Site Number : 0320001

CABA, Buenos Aires, C1414AIF, Argentina

Location

Investigational Site Number : 0320004

Vicente Lopez, Buenos Aires F.D., B1602DQD, Argentina

Location

Investigational Site Number : 0320003

Buenos Aires, C1121ABE, Argentina

Location

Investigational Site Number : 0320006

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0360005

North Adelaide, South Australia, 5006, Australia

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas da PUCRS- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Unidade Ambulatorial de Pesquisa Clinica I - NGP - UNIFESP- Site Number : 0760002

São Paulo, São Paulo, 04037-002, Brazil

Location

Instituto da Criança of Hospital das Clínicas de São Paulo- Site Number : 0760004

São Paulo, São Paulo, 05403-000, Brazil

Location

Clinica de Alergia Martti Antila Site Number : 0760006

Sorocaba, São Paulo, 18040-425, Brazil

Location

Investigational Site Number : 1240003

Québec, G1V 4W2, Canada

Location

Investigational Site Number : 1520001

Valdivia, Los Ríos Region, 5090145, Chile

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 838-0418, Chile

Location

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, 8380453, Chile

Location

Investigational Site Number : 1520007

Viña del Mar, Región de Valparaíso, 2520024, Chile

Location

Investigational Site Number : 1520002

Viña del Mar, Región de Valparaíso, 2520594, Chile

Location

Investigational Site Number : 1700004

Antioquia, 050010, Colombia

Location

Investigational Site Number : 1700002

Cali, 760043, Colombia

Location

Investigational Site Number : 3480006

Budapest, 1089, Hungary

Location

Investigational Site Number : 3480002

Gyula, 5700, Hungary

Location

Investigational Site Number : 3480012

Mezőkövesd, 3400, Hungary

Location

Investigational Site Number : 3480001

Székesfehérvár, 8000, Hungary

Location

Investigational Site Number : 3480008

Szigetvár, 7900, Hungary

Location

Investigational Site Number : 3480003

Töröbálint, 2045, Hungary

Location

Investigational Site Number : 3480007

Zalaegerszeg, 8900, Hungary

Location

Investigational Site Number : 3800003

Florence, 50139, Italy

Location

Investigational Site Number : 3800004

Padua, 35128, Italy

Location

Investigational Site Number : 3800005

Roma, 00146, Italy

Location

Investigational Site Number : 3920013

Chiba, Chiba, 266-0007, Japan

Location

Investigational Site Number : 3920016

Chuo-ku, Chiba, 260-0001, Japan

Location

Investigational Site Number : 3920005

Yotsukaido-shi, Chiba, 284-0003, Japan

Location

Investigational Site Number : 3920015

Fukuoka, Fukuoka, 811-1394, Japan

Location

Investigational Site Number : 3920011

Fukuoka, Fukuoka, 813-0017, Japan

Location

Investigational Site Number : 3920008

Shibukawa, Gunma, 377-8577, Japan

Location

Investigational Site Number : 3920014

Onomichi-shi, Hiroshima, 722-8508, Japan

Location

Investigational Site Number : 3920003

Sapporo, Hokkaido, 064-0821, Japan

Location

Investigational Site Number : 3920012

Tsu, Mie-ken, 514-0125, Japan

Location

Investigational Site Number : 3920010

Ureshino-shi, Saga-ken, 843-0393, Japan

Location

Investigational Site Number : 3920009

Habikino-Shi, 583-0872, Japan

Location

Investigational Site Number : 4400005

Šiauliai, LT-76231, Lithuania

Location

Investigational Site Number : 4400003

Utena, LT-28151, Lithuania

Location

Investigational Site Number : 4400001

Vilnius, LT-08406, Lithuania

Location

Investigational Site Number : 4400004

Vilnius, LT-09108, Lithuania

Location

Investigational Site Number : 4840006

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840004

Chihuahua City, 31200, Mexico

Location

Investigational Site Number : 4840003

Durango, Durango, 34080, Mexico

Location

Investigational Site Number : 4840001

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840002

Veracruz, 91910, Mexico

Location

Investigational Site Number : 6160002

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Investigational Site Number : 6160001

Lodz, Lódzkie, 90-329, Poland

Location

Investigational Site Number : 6430004

Perm, 614066, Russia

Location

Investigational Site Number : 6430002

Saint Petersburg, 193312, Russia

Location

Investigational Site Number : 6430001

Saint Petersburg, 194100, Russia

Location

Investigational Site Number : 6430003

Saint Petersburg, 196158, Russia

Location

Investigational Site Number : 6430005

Saint Petersburg, 197101, Russia

Location

Investigational Site Number : 7100001

Cape Town, 7700, South Africa

Location

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7920005

Adana, 01339, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Ankara, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Istanbul, Turkey (Türkiye)

Location

Investigational Site Number : 8040007

Chernivtsi, 58023, Ukraine

Location

Investigational Site Number : 8040004

Dnipro, 49101, Ukraine

Location

Investigational Site Number : 8040005

Kharkiv, 61093, Ukraine

Location

Investigational Site Number : 8040008

Kryvyi Rig, 50082, Ukraine

Location

Investigational Site Number : 8040001

Kyiv, 03115, Ukraine

Location

Investigational Site Number : 8040002

Zaporizhzhya, 69063, Ukraine

Location

Investigational Site Number : 8040003

Zaporizhzhya, 69076, Ukraine

Location

Related Publications (1)

• Bacharier 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.

  PMID: 37956679 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

dupilumab; Prednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: June 18, 2018
• Study Start: June 21, 2018
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

RU (5); AR (5); TU (4); ME (5); UA (7); CL (5); CA (1); US (12); AU (1); CO (2); HU (7); IT (3); BR (5); LI (4); PL (2); JP (11); ZA (1); ES (1)