Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03747458 | OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps | PHASE3 | ACTIVE NOT_RECRUITING | 72 | — | — | Dec 31, 2018 | Jun 30, 2026 | May 8, 2026 | 31 | United States, Argentina |
Change in nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA). The nasal symptom scale is what is used to score the nasal congestion/obstruction score, which is recorded in the diary. Nasal symptom scale is graded on a scale of 0=no symptom, 1=mild symptom, 2=moderate symptom, 3=severe symptom.
Change in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
| Arm | Type | Description |
|---|---|---|
| OPN-375 186 μg BID | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks |
| Name | Type | Description |
|---|---|---|
| OPN-375 | DRUG | OPN-375, BID |
Inclusion Criteria: 1. Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening). 2. Female subjects, if sexually active, must, 1. be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive pat...