41
Participants
Start Date
May 15, 2021
Primary Completion Date
March 4, 2024
Study Completion Date
November 20, 2024
Dupilumab (blinded)
Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.
Placebo (blinded)
Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.
Dupilumab (open-label)
After completing 6 doses of blinded study drug (dupilumab or placebo), participants can continue into the open-label portion of the study, in which all subjects will receive 12 doses (every 2 weeks for 24 weeks) of dupilumab.
Icahn School of Medicine at Mount Sinai, New York
The Children's Hospital of Philadelphia, Philadelphia
University of Pennsylvania, Philadelphia
University of North Carolina School of Medicine, Chapel Hill
Cincinnati Children's Hospital Medical Center, Cincinnati
Riley Children's Hospital, Indianapolis
Northwestern Medicine Digestive Health Center, Chicago
Texas Children's Hospital, Houston
Children's Hospital Colorado, Aurora
University of Colorado Denver and Hospital, Aurora
University of Utah Hospital, Salt Lake City
Tufts Medical Center, Boston
Regeneron Pharmaceuticals
INDUSTRY
National Institutes of Health (NIH)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER