Condition: Wheezing · Asthma · Sponsor: Sanofi
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
Always discuss trial participation with your own doctor first.
| Phoenix Children's Hospital- Site Number : 8400001 | Phoenix, Arizona, United States | Recruiting |
| Allervie Clinical Research - Destin- Site Number : 8400016 | Destin, Florida, United States | Recruiting |
| EMDA Clinical Research- Site Number : 8400026 | Miami, Florida, United States | Recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011 | Chicago, Illinois, United States | Recruiting |
| Allergy and Asthma Specialist- Site Number : 8400002 | Owensboro, Kentucky, United States | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 | Rochester, Minnesota, United States | Recruiting |
| UBMD Pediatrics- Site Number : 8400013 | Buffalo, New York, United States | Recruiting |
| Boston Children's Health Physicians - Hawthorne- Site Number : 8400010 | Hawthorne, New York, United States | Recruiting |
| UNC Children's Hospital- Site Number : 8400005 | Chapel Hill, North Carolina, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400004 | Cincinnati, Ohio, United States | Recruiting |
| University Hospitals Cleveland Medical Center- Site Number : 8400015 | Cleveland, Ohio, United States | Recruiting |
| Vanderbilt University Medical Center- Site Number : 8400024 | Nashville, Tennessee, United States | Recruiting |
+ 62 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06191315