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
Overview
- Phase
- Phase 3
- Intervention
- Dupilumab (SAR231893/REGN668)
- Conditions
- Asthma
- Sponsor
- Sanofi
- Enrollment
- 378
- Locations
- 81
- Primary Endpoint
- Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
Intervention: Dupilumab (SAR231893/REGN668)
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
Intervention: Asthma controller therapies (incl. prednisone/prednisolone)
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
Intervention: Asthma reliever therapies
Outcomes
Primary Outcomes
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
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.
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline (Day 1) to Week 12
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.
Secondary Outcomes
- Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events(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(Up to Week 52)
- Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time(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(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(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(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(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(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(Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64)
- Serum Concentrations of Dupilumab(Weeks 12, 24, 52 and 64)
- Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab(From first dose of study treatment (Day 1) to Week 64)
- Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64(Baseline (Day 1) to Week 64)
- Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64(Baseline (Day 1) to Week 64)
- Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64(Baseline (Day 1) to Week 64)