EFC14771
A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze
- Sex: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Lung, Asthma
Study Purpose
The purpose of this study is to look at whether dupilumab works in children between 2 to 6 years old with uncontrolled asthma and/or severe asthmatic wheeze. Uncontrolled asthma and/or recurrent severe asthmatic wheeze is defined as the recurrence of wheezing episodes despite the use of background controller medications. The study will also look at how safe and tolerable dupilumab is and how safe it is when taken for a long period.
Who Can Participate
Ages: 2-6 years old
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00002162
- StudyID: 2023-01342
- ClinicalTrials.gov: NCT06191315
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