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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 : December 10, 2018
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.

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.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 377 participants
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 : April 15, 2026
Estimated Study Completion Date : April 15, 2026

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 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. Treatment-emergent adverse events (TEAEs) [ Time Frame: From Day 1 up to Week 64 ]
    The number (n) and percentage (%) of patients experiencing any TEAE


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

  2. 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

  3. Change in absolute FEV1 [ Time Frame: From Day 1 up to Week 64 ]
    Change in absolute FEV1 - Clinically significant changes from baseline

  4. Change in FVC [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced vital capacity (FVC)

  5. Change in FEF [ Time Frame: From Day 1 up to Week 64 ]
    Change in forced expiratory flow (FEF) 25-75%

  6. Assessment of dupilumab concentration [ Time Frame: From Day 1 up to Week 64 ]
    Serum dupilumab concentrations - Changes from first dupilumab injection

  7. Assessment of immunogenicity [ Time Frame: From Day 1 up to Week 64 ]
    Titers of Anti-dupilumab antibodies

  8. Assessment of blood Eosinophil count [ Time Frame: From Day 1 up to Week 64 ]
    Blood: Eosinophil count

  9. Assessment of immunoglobulins [ Time Frame: From Day 1 up to Week 64 ]
    Serum: Immunoglobulins (Ig)

  10. Assessment of total immunoglobulin E (IgE) [ Time Frame: From Day 1 up to Week 64 ]
    Serum: total IgE



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Ages Eligible for Study:   7 Years to 12 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] 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.


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


Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
United States, Arizona
Investigational Site Number 8400002 Recruiting
Gilbert, Arizona, United States, 85234
Investigational Site Number 8400012 Recruiting
Tucson, Arizona, United States, 85274
United States, California
Investigational Site Number 8400001 Recruiting
Rolling Hills Estates, California, United States, 90274
United States, New York
Investigational Site Number 8400013 Recruiting
New York, New York, United States, 10032
Investigational Site Number 8400007 Recruiting
Rochester, New York, United States, 14607
United States, North Carolina
Investigational Site Number 8400004 Recruiting
Charlotte, North Carolina, United States, 28277
United States, Texas
Investigational Site Number 8400003 Recruiting
San Antonio, Texas, United States, 78229
Argentina
Investigational Site Number 0320002 Recruiting
Caba, Argentina, C1122AAK
Investigational Site Number 0320001 Recruiting
Caba, Argentina, C1414AIF
Brazil
Investigational Site Number 0760006 Recruiting
Sorocaba, Brazil, 18040-425
Canada
Investigational Site Number 1240003 Recruiting
Quebec, Canada, G1V 4W2
Chile
Investigational Site Number 1520005 Recruiting
Santiago, Chile, 838-0418
Investigational Site Number 1520001 Recruiting
Valdivia, Chile
Investigational Site Number 1520002 Recruiting
Viña Del Mar, Chile, 2520594
Hungary
Investigational Site Number 3480008 Recruiting
Szigetvár, Hungary, 7900
Investigational Site Number 3480001 Recruiting
Székesfehérvár, Hungary, 8000
Investigational Site Number 3480007 Recruiting
Zalaegerszeg, Hungary, 8900
Lithuania
Investigational Site Number 4400005 Recruiting
Siauliai, Lithuania, LT-76231
Investigational Site Number 4400003 Recruiting
Utena, Lithuania, LT-28151
Mexico
Investigational Site Number 4840003 Recruiting
Durango, Durango, Mexico, 34080
Investigational Site Number 4840002 Recruiting
Veracruz, Mexico, 91910
Poland
Investigational Site Number 6160001 Recruiting
Lodz, Poland, 90-329
Investigational Site Number 6160002 Recruiting
Poznan, Poland, 60-693
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03560466     History of Changes
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: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Prednisolone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors