OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter
Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents
with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total
planned number of subjects is approximately 120 adolescents (12-17 years of age) who will be
randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg:
Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.