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NCT02948959 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Dupilumab in Children With Uncontrolled Asthma
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 408
- Enrollment target
NCT02948959: Completed Phase 3 study, sponsored by Sanofi.
NCT02948959 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02948959, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 408 participants
- Enrollment target
Study 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.
Primary Outcome
A severe asthma exacerbation event was defined as a deterioration of asthma during the 52-week treatment period requiring: use of systemic corticosteroids for \>=3 days; and/or hospitalization or emergency room visit because of asthma requiring systemic corticosteroid treatment. Annualized event rate was defined as the total number of severe exacerbation events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment per
Interventions
- DRUG Placebo
- DRUG Dupilumab
- DRUG Asthma Controller Therapies
- DRUG Asthma Reliever Therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2017-04-21 |
| Est. Completion | 2020-08-26 |
| Phase | Phase 3 |
What the finished NCT02948959 record still lists
NCT02948959 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02948959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02948959 about?
NCT02948959 is a clinical study titled "Evaluation of Dupilumab in Children With Uncontrolled Asthma". 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...
What is the current status of trial NCT02948959?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2017-04-21. Estimated completion is 2020-08-26.
What interventions are being tested in trial NCT02948959?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Asthma Controller Therapies (DRUG), Asthma Reliever Therapies (DRUG).
Who is sponsoring clinical trial NCT02948959?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02948959's enrollment target sits among peer trials
408 911th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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