Trials / Completed
CompletedNCT02948959
Evaluation of Dupilumab in Children With Uncontrolled Asthma
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 408 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. Secondary Objective: To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * The safety and tolerability of dupilumab. * The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * The dupilumab systemic exposure and incidence of anti-drug antibodies. * The evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.
Detailed description
The total study duration per participant was up to 69 weeks, consisted of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| DRUG | Placebo | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| DRUG | Asthma Controller Therapies | Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhaled, oral |
| DRUG | Asthma Reliever Therapies | Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled |
Timeline
- Start date
- 2017-04-21
- Primary completion
- 2020-08-26
- Completion
- 2020-08-26
- First posted
- 2016-10-31
- Last updated
- 2022-03-28
- Results posted
- 2021-10-20
Locations
99 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02948959. Inclusion in this directory is not an endorsement.