A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Exclusion Criteria

• •Have received a dose of lebrikizumab.
• •Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
• •Allergen immunotherapy (subcutaneous immunotherapy \[SCIT\]/sublingual immunotherapy \[SLIT\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).
• •Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.
• •Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
• •1. B cell-depleting biologics, including rituximab, within 6 months.
• •2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
• •3. Systemic immunosuppressants within 4 weeks prior to baseline.
• •Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening
• •Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS
• •Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:
• •1. Nasal septal deviation occluding at least one nostril.
• •2. Antrochoanal polyps.
• •3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
• •4. Ongoing rhinitis medicamentosa.
• •5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.
• •6. A nasal cavity tumor (malignant or benign).
• •7. Evidence of fungal rhinosinusitis.
• •Have anosmia from COVID or any reason other than CRSwNP.
• •Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
• •Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.