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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06338995 | A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) | PHASE3 | RECRUITING | 510 | — | — | Apr 29, 2024 | Mar 1, 2028 | Jun 3, 2026 | 194 | United States, Argentina +18 |
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.
The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.
| Arm | Type | Description |
|---|---|---|
| Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) | EXPERIMENTAL | Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Note: Enrollment of adolescents will be open-label, with all adolescents assigned to the lebrikizumab Q2W/Q4W treatment arm. |
| Lebrikizumab Q2W/every 8 weeks (Q8W) | EXPERIMENTAL | Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. |
| Placebo Q2W/Q4W | PLACEBO_COMPARATOR | Placebo will be given as SC injection. Participants will receive background therapy with INCS. |
| Name | Type | Description |
|---|---|---|
| LY3650150 | DRUG | Administered SC. |
| Placebo | DRUG | Administered SC. |
| Standard therapy for INCS | DRUG | Administered as intranasal spray. |
Inclusion Criteria: * Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). * Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. * Endoscopic bilateral NPS sco...