Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
- Conditions
- Asthma
- Interventions
- Drug: Asthma controller therapies (incl. prednisone/prednisolone)Drug: Asthma reliever therapies
- Registration Number
- NCT03560466
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab (SAR231893/REGN668) Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks Dupilumab Asthma controller therapies (incl. prednisone/prednisolone) Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks Dupilumab Asthma reliever therapies Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
- Primary Outcome Measures
Name Time Method The number of patients experiencing any treatment emergent adverse event (TEAE) From Day 1 up to Week 64 The number of patients experiencing any TEAE.
Japan sub-study: Change from baseline in pre-bronchodilator percentage (%) predicted FEV1 at Week 12 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
Name Time Method Annualized rate of severe asthma exacerbation events during the treatment period From Day 1 up to Week 52 Annualized rate of severe asthma exacerbation events during the treatment period.
Change from baseline in absolute FEV1 Baseline to Week 64 Change from baseline in absolute FEV1.
Change from baseline in % predicted FEV1 Baseline to Week 64 Change from baseline in % predicted FEV1.
Change from baseline in FVC Baseline to Week 64 Change from baseline in forced vital capacity (FVC).
Change from baseline in FEF 25 to 75% Baseline to Week 64 Change from baseline in forced expiratory flow (FEF) 25-75%.
Serum dupilumab concentrations From Day 1 up to Week 64 Serum dupilumab concentrations.
Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab From Day 1 up to Week 64 Incidence of treatment-emergent ADA against dupilumab.
Blood eosinophil counts From Day 1 up to Week 64 Blood eosinophil counts.
Serum total IgE From Day 1 up to Week 64 Serum total IgE.
Japan sub-study: Annualized rate of severe asthma exacerbation events during the treatment period From Day 1 up to Week 52 Annualized rate of severe asthma exacerbation events, during the treatment period.
Japan sub-study: Change from baseline in pre-bronchodilator % predicted FEV1 at Weeks 2, 4, 8, 24, 52, and 64 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.
Japan sub-stud: Change from baseline in absolute FEV1 Baseline to Week 2, 4, 8, 12, 24, 52 and 64 Change from baseline in absolute FEV1.
Japan sub-study: Change from baseline in FVC Baseline to Week 2, 4, 8, 12, 24, 52 and 64 Change from baseline in FVC.
Japan sub-study: Change from baseline in FEF 25-75% Baseline to Week 2, 4, 8, 12, 24, 52 and 64 Change from baseline in FEF 25-75%.
Japan sub-study: Change from baseline in ACQ-IA Baseline to Week 2, 4, 8, 12, 24, 36, 52, and 64 Change from baseline in Asthma Control Questionnaire-Interviewer Administered (ACQ-IA).
Japan sub-study: The number of patients experiencing any TEAEs From Day 1 up to Week 64 The number of patients experiencing any TEAEs.
Japan sub-study: Serum dupilumab concentrations From Day 1 up to week 64 Serum dupilumab concentrations.
Japan sub-study: Incidence of treatment-emergent ADA against dupilumab From Day 1 up to Week 64 Incidence of treatment-emergent ADA against dupilumab.
Japan sub-study: Serum total immunoglobulin E (IgE) From Day 1 up to Week 64 Serum total immunoglobulin E (IgE).
Japan sub-study: Change from Baseline in FeNO Baseline to Weeks 2, 4, 8, 12, 24, 52, and 64 Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO).
Trial Locations
- Locations (81)
Arizona Allergy and Immunology Research- Site Number : 8400002
🇺🇸Gilbert, Arizona, United States
Asthma and Airway Disease Research Center Site Number : 8400012
🇺🇸Tucson, Arizona, United States
Peninsula Research Associates Site Number : 8400001
🇺🇸Rolling Hills Estates, California, United States
Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006
🇺🇸Saint Louis, Missouri, United States
Somnos Clinical Research Site Number : 8400022
🇺🇸Lincoln, Nebraska, United States
Northwell Health- Site Number : 8400023
🇺🇸Great Neck, New York, United States
Columbia University Medical Center- Site Number : 8400013
🇺🇸New York, New York, United States
Rochester Regional Health- Site Number : 8400007
🇺🇸Rochester, New York, United States
Immunocarolina LLC Site Number : 8400004
🇺🇸Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center Site Number : 8400008
🇺🇸Cincinnati, Ohio, United States
Scroll for more (71 remaining)Arizona Allergy and Immunology Research- Site Number : 8400002🇺🇸Gilbert, Arizona, United States