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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03681093 | Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma | PHASE3 | COMPLETED | 98 | — | — | Mar 26, 2019 | Jun 10, 2020 | Oct 11, 2021 | 25 | United States, Argentina +7 |
Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps. Baseline NPS is defined as the last measurement performed on or before the date of randomization. A negative change from baseline in NPS is considered a favorable outcome.
| Arm | Type | Description |
|---|---|---|
| Fevipiprant 150 mg | EXPERIMENTAL | Fevipiprant (QAW039) 150 mg once daily orally |
| Fevipiprant 450 mg | EXPERIMENTAL | Fevipiprant (QAW039) 450 mg once daily orally |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily orally |
| Name | Type | Description |
|---|---|---|
| Fevipiprant 150 mg | DRUG | Fevipiprant (QAW039) 150 mg once daily administered orally as tablet |
| Fevipiprant 450 mg | DRUG | Fevipiprant (QAW039) 450 mg once daily administered orally as tablet |
| Placebo | DRUG | Placebo once daily administered orally as tablet |
Inclusion Criteria: * Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score \>= 4 with minimum score of 2 in each nostril. * Concomitant diagnosis of asthma for a period of at least 6 months prior to screening. * Patients on stable asthma treatment of at least inhal...