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

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ClinicalTrials.gov Identifier: NCT03560466
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE June 21, 2018
Estimated Primary Completion Date April 15, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Treatment-emergent adverse events (TEAEs) [ Time Frame: From Day 1 up to Week 64 ]
The number (n) and percentage (%) of patients experiencing any TEAE
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
Treatment-emergent adverse events [ Time Frame: From Day 1 up to Week 64 ]
The number (n) of patients experiencing any treatment-emergent adverse events (TEAEs)
Change History Complete list of historical versions of study NCT03560466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Severe asthma exacerbation events [ Time Frame: From Day 1 up to Week 52 ]
    Annualized rate of severe asthma exacerbation events, during the treatment period
  • Change in % predicted FEV1 [ Time Frame: From Day 1 up to Week 64 ]
    Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
  • Change in absolute FEV1 [ Time Frame: From Day 1 up to Week 64 ]
    Change in absolute FEV1 - Clinically significant changes from baseline
  • Change in FVC [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced vital capacity (FVC)
  • Change in FEF [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced expiratory flow (FEF) 25-75%
  • Assessment of dupilumab concentration [ Time Frame: From Day 1 up to Week 64 ]
    Serum dupilumab concentrations - Changes from first dupilumab injection
  • Assessment of immunogenicity [ Time Frame: From Day 1 up to Week 64 ]
    Titers of Anti-dupilumab antibodies
  • Assessment of blood Eosinophil count [ Time Frame: From Day 1 up to Week 64 ]
    Blood: Eosinophil count
  • Assessment of immunoglobulins [ Time Frame: From Day 1 up to Week 64 ]
    Serum: Immunoglobulins (Ig)
  • Assessment of total immunoglobulin E (IgE) [ Time Frame: From Day 1 up to Week 64 ]
    Serum: total IgE
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Severe asthma exacerbation events [ Time Frame: From Day 1 up to Week 64 ]
    Annualized rate of severe asthma exacerbation events, during the treatment period
  • Change in % predicted FEV1 [ Time Frame: From Day 1 up to Week 64 ]
    Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
  • Change in absolute FEV1 [ Time Frame: From Day 1 up to Week 64 ]
    Change in absolute FEV1 - Clinically significant changes from baseline
  • Change in FVC [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced vital capacity (FVC)
  • Change in FEF [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced expiratory flow (FEF) 25-75%
  • Assessment of dupilumab concentration [ Time Frame: From Day 1 up to Week 64 ]
    Serum dupilumab concentrations - Changes from first dupilumab injection
  • Assessment of immunogenicity [ Time Frame: From Day 1 up to Week 64 ]
    Titers of Anti-dupilumab antibodies
  • Assessment of blood Eosinophil count [ Time Frame: From Day 1 up to Week 64 ]
    Blood: Eosinophil count
  • Assessment of immunoglobulins [ Time Frame: From Day 1 up to Week 64 ]
    Serum: Immunoglobulins (Ig)
  • Assessment of total IgE [ Time Frame: From Day 1 up to Week 64 ]
    Serum: total IgE
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Official Title  ICMJE 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
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.

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.
Detailed Description Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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

Study Arms  ICMJE Experimental: Dupilumab
Doses of dupilumab will be administered every 2 weeks added to current controller medications for 52 weeks
Interventions:
  • Drug: Dupilumab (SAR231893/REGN668)
  • Drug: Asthma controller therapies (incl. prednisone/prednisolone)
  • Drug: Asthma reliever therapies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
377
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
236
Estimated Study Completion Date  ICMJE April 15, 2026
Estimated Primary Completion Date April 15, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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] Visit 28, considered as Visit 1 for LTS14424).

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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Chile,   Hungary,   Lithuania,   Mexico,   Poland,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03560466
Other Study ID Numbers  ICMJE LTS14424
2017-003317-25 ( EudraCT Number )
U1111-1200-1757 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP