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LY3650150 · 2 trials · 2 indications
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.
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
| 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...
LY3650150, also known as lebrikizumab, is an investigational small molecule being studied for chronic rhinosinusitis with nasal polyps (CRSwNP) and perennial allergic rhinitis (PAR). It is being evaluated in Phase 3 clinical trials for these ENT conditions.
LY3650150 is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied for its effects on inflammatory conditions of the upper airways, including chronic rhinosinusitis with nasal polyps and perennial allergic rhinitis.
LY3650150 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting Phase 3 clinical trials for this investigational drug.
LY3650150 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials are ongoing or recently completed for chronic rhinosinusitis with nasal polyps and perennial allergic rhinitis.
LY3650150 is being studied in two Phase 3 trials. NCT06338995, called CONTRAST-NP, is recruiting 510 participants with chronic rhinosinusitis with nasal polyps. NCT06339008, called PREPARED-1, is active but not recruiting 450 adults with perennial allergic rhinitis. Both are randomized, double-blind, placebo-controlled studies.
Yes, LY3650150 is also known as lebrikizumab. The clinical trials for this drug use the name lebrikizumab in their titles, and LY3650150 is the code name used by the developer, Eli Lilly and Company.