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

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.

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Dupilumab (SAR231893/REGN668); Drug: Asthma controller therapies (incl. prednisone/prednisolone); Drug: Asthma reliever therapies

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 Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1121ABE
    • Investigational Site Number : 0320003
  • Mendoza, Argentina, 5500
    • Investigational Site Number : 0320006
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1414AIF
      • Investigational Site Number : 0320001
    • CABA, Buenos Aires, Argentina, C1122AAK
      • Investigational Site Number : 0320002
  • Buenos Aires F.D.
    • Vicente Lopez, Buenos Aires F.D., Argentina, B1602DQD
      • Investigational Site Number : 0320004
• Australia
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Investigational Site Number : 0360005
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS- Site Number : 0760007
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila Site Number : 0760006
    • São Paulo, São Paulo, Brazil, 04037-002
      • Unidade Ambulatorial de Pesquisa Clinica I - NGP - UNIFESP- Site Number : 0760002
    • São Paulo, São Paulo, Brazil, 05403-000
      • Instituto da Criança of Hospital das Clínicas de São Paulo- Site Number : 0760004
• Canada
  • Québec, Canada, G1V 4W2
    • Investigational Site Number : 1240003
• Chile
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5090145
      • Investigational Site Number : 1520001
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 838-0418
      • Investigational Site Number : 1520005
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380453
      • Investigational Site Number : 1520009
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520024
      • Investigational Site Number : 1520007
    • Viña del Mar, Región de Valparaíso, Chile, 2520594
      • Investigational Site Number : 1520002
• Colombia
  • Antioquia, Colombia, 050010
    • Investigational Site Number : 1700004
  • Cali, Colombia, 760043
    • Investigational Site Number : 1700002
• Hungary
  • Budapest, Hungary, 1089
    • Investigational Site Number : 3480006
  • Gyula, Hungary, 5700
    • Investigational Site Number : 3480002
  • Mezőkövesd, Hungary, 3400
    • Investigational Site Number : 3480012
  • Szigetvár, Hungary, 7900
    • Investigational Site Number : 3480008
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number : 3480001
  • Töröbálint, Hungary, 2045
    • Investigational Site Number : 3480003
  • Zalaegerszeg, Hungary, 8900
    • Investigational Site Number : 3480007
• Italy
  • Florence, Italy, 50139
    • Investigational Site Number : 3800003
  • Padua, Italy, 35128
    • Investigational Site Number : 3800004
  • Roma, Italy, 00146
    • Investigational Site Number : 3800005
• Japan
  • Habikino-Shi, Japan, 583-0872
    • Investigational Site Number : 3920009
  • Chiba
    • Chiba, Chiba, Japan, 266-0007
      • Investigational Site Number : 3920013
    • Chuo-ku, Chiba, Japan, 260-0001
      • Investigational Site Number : 3920016
    • Yotsukaido-shi, Chiba, Japan, 284-0003
      • Investigational Site Number : 3920005
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-1394
      • Investigational Site Number : 3920015
    • Fukuoka, Fukuoka, Japan, 813-0017
      • Investigational Site Number : 3920011
  • Gunma
    • Shibukawa, Gunma, Japan, 377-8577
      • Investigational Site Number : 3920008
  • Hiroshima
    • Onomichi-shi, Hiroshima, Japan, 722-8508
      • Investigational Site Number : 3920014
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0821
      • Investigational Site Number : 3920003
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-0125
      • Investigational Site Number : 3920012
  • Saga-ken
    • Ureshino-shi, Saga-ken, Japan, 843-0393
      • Investigational Site Number : 3920010
• Lithuania
  • Utena, Lithuania, LT-28151
    • Investigational Site Number : 4400003
  • Vilnius, Lithuania, LT-08406
    • Investigational Site Number : 4400001
  • Vilnius, Lithuania, LT-09108
    • Investigational Site Number : 4400004
  • Šiauliai, Lithuania, LT-76231
    • Investigational Site Number : 4400005
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840006
  • Chihuahua City, Mexico, 31200
    • Investigational Site Number : 4840004
  • Durango, Durango, Mexico, 34080
    • Investigational Site Number : 4840003
  • Monterrey, Nuevo León, Mexico, 64460
    • Investigational Site Number : 4840001
  • Veracruz, Mexico, 91910
    • Investigational Site Number : 4840002
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-693
      • Investigational Site Number : 6160002
  • Lódzkie
    • Lodz, Lódzkie, Poland, 90-329
      • Investigational Site Number : 6160001
• Russia
  • Perm, Russia, 614066
    • Investigational Site Number : 6430004
  • Saint Petersburg, Russia, 193312
    • Investigational Site Number : 6430002
  • Saint Petersburg, Russia, 194100
    • Investigational Site Number : 6430001
  • Saint Petersburg, Russia, 196158
    • Investigational Site Number : 6430003
  • Saint Petersburg, Russia, 197101
    • Investigational Site Number : 6430005
• South Africa
  • Cape Town, South Africa, 7700
    • Investigational Site Number : 7100001
• Spain
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240001
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01339
    • Investigational Site Number : 7920005
  • Ankara, Turkey (Türkiye)
    • Investigational Site Number : 7920001
  • Istanbul, Turkey (Türkiye)
    • Investigational Site Number : 7920003
  • Istanbul, Turkey (Türkiye)
    • Investigational Site Number : 7920004
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Investigational Site Number : 8040007
  • Dnipro, Ukraine, 49101
    • Investigational Site Number : 8040004
  • Kharkiv, Ukraine, 61093
    • Investigational Site Number : 8040005
  • Kryvyi Rig, Ukraine, 50082
    • Investigational Site Number : 8040008
  • Kyiv, Ukraine, 03115
    • Investigational Site Number : 8040001
  • Zaporizhzhya, Ukraine, 69063
    • Investigational Site Number : 8040002
  • Zaporizhzhya, Ukraine, 69076
    • Investigational Site Number : 8040003
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Arizona Allergy and Immunology Research- Site Number : 8400002
    • Tucson, Arizona, United States, 85274
      • Asthma and Airway Disease Research Center Site Number : 8400012
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates Site Number : 8400001
  • Missouri
    • St Louis, Missouri, United States, 63110-1077
      • Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Somnos Clinical Research Site Number : 8400022
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health- Site Number : 8400023
    • New York, New York, United States, 10032
      • Columbia University Medical Center- Site Number : 8400013
    • Rochester, New York, United States, 14607
      • Rochester Regional Health- Site Number : 8400007
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Immunocarolina LLC Site Number : 8400004
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center Site Number : 8400008
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC- Site Number : 8400024
  • Texas
    • San Antonio, Texas, United States, 78229
      • Allergy & Asthma Research Center- Site Number : 8400003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria :

• 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).

Exclusion criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dupilumab; 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); Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc); Drug: Asthma controller therapies (incl. prednisone/prednisolone); Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral; Drug: Asthma reliever therapies; Pharmaceutical form: powder or solution Route of administration: inhaled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (Day 1) to Week 64

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone; dupilumab
• Other Study ID Numbers: LTS14424; 2017-003317-25 (EudraCT Number); U1111-1200-1757 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No