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Trial record 1 of 1 for:    NCT03560466
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Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560466
Recruitment Status : Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab (SAR231893/REGN668) Drug: Asthma controller therapies (incl. prednisone/prednisolone) Drug: Asthma reliever therapies Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

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





Primary Outcome Measures :
  1. The number of patients experiencing any treatment emergent adverse event (TEAE) [ Time Frame: From Day 1 up to Week 64 ]
    The number of patients experiencing any TEAE.

  2. Japan sub-study: Change from baseline in pre-bronchodilator percentage (%) predicted FEV1 at Week 12 [ Time Frame: Baseline to Week 12 ]
    Change from baseline in pre-bronchodilator percentage (%) predicted forced expiratory volume in 1 second (FEV1) at week 12.


Secondary Outcome Measures :
  1. Annualized rate of severe asthma exacerbation events during the treatment period [ Time Frame: From Day 1 up to Week 52 ]
    Annualized rate of severe asthma exacerbation events during the treatment period.

  2. Change from baseline in % predicted FEV1 [ Time Frame: Baseline to Week 64 ]
    Change from baseline in % predicted FEV1.

  3. Change from baseline in absolute FEV1 [ Time Frame: Baseline to Week 64 ]
    Change from baseline in absolute FEV1.

  4. Change from baseline in FVC [ Time Frame: Baseline to Week 64 ]
    Change from baseline in forced vital capacity (FVC).

  5. Change from baseline in FEF 25 to 75% [ Time Frame: Baseline to Week 64 ]
    Change from baseline in forced expiratory flow (FEF) 25-75%.

  6. Serum dupilumab concentrations [ Time Frame: From Day 1 up to Week 64 ]
    Serum dupilumab concentrations.

  7. Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab [ Time Frame: From Day 1 up to Week 64 ]
    Incidence of treatment-emergent ADA against dupilumab.

  8. Blood eosinophil counts [ Time Frame: From Day 1 up to Week 64 ]
    Blood eosinophil counts.

  9. Serum total IgE [ Time Frame: From Day 1 up to Week 64 ]
    Serum total IgE.

  10. Japan sub-study: Annualized rate of severe asthma exacerbation events during the treatment period [ Time Frame: From Day 1 up to Week 52 ]
    Annualized rate of severe asthma exacerbation events, during the treatment period.

  11. Japan sub-study: Change from baseline in pre-bronchodilator % predicted FEV1 at Weeks 2, 4, 8, 24, 52, and 64 [ Time Frame: Baseline to Week 2, 4, 8, 24, 52 and 64 ]
    Change from baseline in pre-bronchodilator % predicted FEV1 at Weeks 2, 4, 8, 24, 52, and 64.

  12. Japan sub-stud: Change from baseline in absolute FEV1 [ Time Frame: Baseline to Week 2, 4, 8, 12, 24, 52 and 64 ]
    Change from baseline in absolute FEV1.

  13. Japan sub-study: Change from baseline in FVC [ Time Frame: Baseline to Week 2, 4, 8, 12, 24, 52 and 64 ]
    Change from baseline in FVC.

  14. Japan sub-study: Change from baseline in FEF 25-75% [ Time Frame: Baseline to Week 2, 4, 8, 12, 24, 52 and 64 ]
    Change from baseline in FEF 25-75%.

  15. Japan sub-study: Change from baseline in ACQ-IA [ Time Frame: Baseline to Week 2, 4, 8, 12, 24, 36, 52, and 64 ]
    Change from baseline in Asthma Control Questionnaire-Interviewer Administered (ACQ-IA).

  16. Japan sub-study: The number of patients experiencing any TEAEs [ Time Frame: From Day 1 up to Week 64 ]
    The number of patients experiencing any TEAEs.

  17. Japan sub-study: Serum dupilumab concentrations [ Time Frame: From Day 1 up to week 64 ]
    Serum dupilumab concentrations.

  18. Japan sub-study: Incidence of treatment-emergent ADA against dupilumab [ Time Frame: From Day 1 up to Week 64 ]
    Incidence of treatment-emergent ADA against dupilumab.

  19. Japan sub-study: Serum total immunoglobulin E (IgE) [ Time Frame: From Day 1 up to Week 64 ]
    Serum total immunoglobulin E (IgE).

  20. Japan sub-study: Change from Baseline in FeNO [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 24, 52, and 64 ]
    Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560466


Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03560466    
Other Study ID Numbers: LTS14424
2017-003317-25 ( EudraCT Number )
U1111-1200-1757 ( Other Identifier: UTN )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents