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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07484230 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | PHASE3 | NOT YET_RECRUITING | 20 | — | — | May 8, 2026 | Oct 10, 2028 | Mar 20, 2026 | - | — |
| NCT07424144 | An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps | PHASE3 | ENROLLING BY_INVITATION | 380 | — | — | Mar 12, 2026 | Dec 12, 2028 | May 27, 2026 | 15 | United States, Australia +5 |
| NCT06834347 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | PHASE3 | ACTIVE NOT_RECRUITING | 231 | — | — | Feb 12, 2025 | Sep 16, 2027 | May 20, 2026 | 121 | United States, Argentina +19 |
| NCT06834360 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | PHASE3 | ACTIVE NOT_RECRUITING | 216 | — | — | Feb 6, 2025 | Oct 11, 2027 | Jun 2, 2026 | 111 | United States, Argentina +21 |
The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).
All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit
The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
| Arm | Type | Description |
|---|---|---|
| Itepekimab high dose | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks |
| Itepekimab low dose | EXPERIMENTAL | SC administration of Itepekimab low dose for 52 weeks |
| Placebo | PLACEBO_COMPARATOR | SC administration of matching placebo for 52 weeks |
| Name | Type | Description |
|---|---|---|
| Itepekimab (SAR440340) | DRUG | Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous |
| Mometasone furoate nasal spray (MFNS) | DRUG | Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray |
Inclusion Criteria: * Participants must be 18 years of age or older. * Participants with a history of CRSwNP for at least 1 year. * Participants must have at least one of the following features: * Prior sinonasal surgery for NP. * Worsening symptoms of CRS requiring treatment with SCS within t...